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The Fassier-Duval Telescopic IM System

EUDAMEDFDA UDI

Class I (EU MDR)

Ref FC-WHL100Model CUTTING WHEEL

by OrthoPediatrics Canada ULC

Identity

Trade Name
The Fassier-Duval Telescopic IM System EUDAMED
FASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
Generic Name
Arthrodesis intramedullary nail, non-distracting FDA UDI
Orthopaedic bone screw (non-sliding) FDA UDI
Fluted surgical drill bit, reusable FDA UDI
Cannulated surgical drill bit, reusable FDA UDI
Bone trephine, reusable FDA UDI
Orthopaedic guidewire, single-use FDA UDI
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Metal-cutting bur FDA UDI
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Surgical screwdriver, reusable FDA UDI
Device Name
Male Short Component for Ø4.8mm Assy FDA UDI
LOCKING PIN Ø1.6mm x 150mm FDA UDI
STERILE MALE LONG COMPONENT FOR Ø3.2mm ASSY FDA UDI
PEG DRILL 2.4 mm FDA UDI
PEG DRILL 2.0 mm FDA UDI
STERILE MALE SHORT COMPONENT FOR Ø4.8mm ASSY FDA UDI
STERILE FEMORAL FEMALE COMPONENT FOR Ø6.4mm ASSY FDA UDI
Long Femoral Nail Assy Ø4.8mm x 409mm FDA UDI
STERILE TIBIA/HUMERAL FEMALE COMPONENT FOR Ø4.8mm ASSY FDA UDI
STERILE MALE LONG COMPONENT FOR Ø6.4mm ASSY FDA UDI
DRILL Ø5.6mm FDA UDI
LON Tibial/ Humeral Nail Assy Ø4.8mm x 400mm FDA UDI
Short Proximal Long Distal Nail Assy Ø5.6mm x 410mm FDA UDI
STERILE FEMORAL FEMALE COMPONENT FOR Ø3.2mm ASSY FDA UDI
FEMALE TREPHINE 8.0MM FDA UDI
PEG DRILL 2.8 mm FDA UDI
Male Long Component for Ø6.4mm Assy FDA UDI
Short Tibial/Humeral Nail Assy Ø5.6mm x 405mm FDA UDI
Short Proximal Long Distal Nail Assy Ø4.8mm x 409mm FDA UDI
FD GUIDE WIRE Ø1.8mm - PACKAGE OF 6 FDA UDI
LON Femoral Nail Assy Ø4.8 mm x 400mm FDA UDI
STERILE MALE SHORT COMPONENT FOR Ø4.0mm ASSY FDA UDI
MALE DRIVER Ø3.2mm FDA UDI
Male Short Component for Ø3.2mm Assy FDA UDI
MALE DRIVER Ø5.6mm FDA UDI
PEG Ø2.0mm x 40mm FDA UDI
LON Tibial/Humeral Assy Ø4.0mm x 330mm FDA UDI
MALE DRIVER Ø4.0mm FDA UDI
Femoral Female Component for Ø5.6mm Assy FDA UDI
STERILE FEMORAL FEMALE COMPONENT FOR Ø4.8mm ASSY FDA UDI
STERILE TIBIA/HUMERAL FEMALE COMPONENT FOR Ø3.2mm ASSY FDA UDI
PEG Ø2.8mm x 40mm FDA UDI
CUTTING WHEEL FOR THE FEMALE COMPONENT CUTTER FDA UDI
COIL-PULLER SHAFT Ø5.6mm FDA UDI
Short Tibial/Humeral Nail Assy Ø4.8mm x 404mm FDA UDI
PEG Ø2.8mm x 20mm FDA UDI
Short Proximal Long Distal Nail Assy Ø3.2 mm FDA UDI
Short Femoral Nail Assy Ø6.4mm x 407mm FDA UDI
PEG Ø2.8mm x 56mm FDA UDI
PEG Ø2.8mm x 60mm FDA UDI
TREPHINE 4.0mm FDA UDI
PEG Ø2.0mm x 44mm FDA UDI
Short Proximal Long Distal Nail Assy Ø4.0mm x 338mm FDA UDI
4.0-6.4 CARTRIDGE FDA UDI
COIL-PULLER SHAFT Ø4.0mm FDA UDI
Long Femoral Nail Assy Ø3.2mm FDA UDI
Femoral Female Component for Ø4.0mm Assy FDA UDI
T8 TORX SCREWDRIVER FDA UDI
PEG Ø2.8mm x 32mm FDA UDI
Male LON Component for Ø5.6mm Assy FDA UDI
Model / Reference
CUTTING WHEEL EUDAMED
FC-WHL100 EUDAMEDFDA UDI
M048-SS-70 FDA UDI
FD-LCP-160 FDA UDI
M032-SS-100-S FDA UDI
PEG-PGD124 FDA UDI
PEG-PGD120 FDA UDI
M048-SS-70-S FDA UDI
F064-SS-S FDA UDI
FD-048(L)-SS FDA UDI
T048-SS-S FDA UDI
M064-SS-150-S FDA UDI
DR156 FDA UDI
FDLON-T048-SS FDA UDI
FD-056(SPL)-SS FDA UDI
F032-SS-S FDA UDI
FTRP108 FDA UDI
PEG-PGD128 FDA UDI
M064-SS-150 FDA UDI
FD-056(SPS)-SS FDA UDI
FD-048(SPL)-SS FDA UDI
G-WIRE 018-PKG6 FDA UDI
FDLON-F048-SS FDA UDI
M040-SS-60-S FDA UDI
MDR132 FDA UDI
M032-SS-50 FDA UDI
MDR156 FDA UDI
FD-PEG-20-040 FDA UDI
FDLON-T040-SS FDA UDI
MDR140 FDA UDI
F056-SS FDA UDI
F048-SS-S FDA UDI
T032-SS-S FDA UDI
FD-PEG-28-040 FDA UDI
MR256-S FDA UDI
FD-048(SPS)-SS FDA UDI
FD-PEG-28-020 FDA UDI
FD-032(SPL)-SS FDA UDI
FD-064(S)-SS FDA UDI
FD-PEG-28-056 FDA UDI
FD-PEG-28-060 FDA UDI
TRP140 FDA UDI
FD-PEG-20-044 FDA UDI
FD-040(SPL)-SS FDA UDI
FRT250 FDA UDI
MR240-S FDA UDI
FD-032(L)-SS FDA UDI
F040-SS FDA UDI
GIN-TRX800 FDA UDI
FD-PEG-28-032 FDA UDI
M056-SS-LON FDA UDI
Description
Male Short Component for Ø4.8mm Assy FDA UDI
LOCKING PIN Ø1.6mm x 150mm FDA UDI
STERILE MALE LONG COMPONENT FOR Ø3.2mm ASSY FDA UDI
PEG DRILL 2.4 mm FDA UDI
PEG DRILL 2.0 mm FDA UDI
STERILE MALE SHORT COMPONENT FOR Ø4.8mm ASSY FDA UDI
STERILE FEMORAL FEMALE COMPONENT FOR Ø6.4mm ASSY FDA UDI
Long Femoral Nail Assy Ø4.8mm x 409mm FDA UDI
STERILE TIBIA/HUMERAL FEMALE COMPONENT FOR Ø4.8mm ASSY FDA UDI
STERILE MALE LONG COMPONENT FOR Ø6.4mm ASSY FDA UDI
DRILL Ø5.6mm FDA UDI
LON Tibial/ Humeral Nail Assy Ø4.8mm x 400mm FDA UDI
Short Proximal Long Distal Nail Assy Ø5.6mm x 410mm FDA UDI
STERILE FEMORAL FEMALE COMPONENT FOR Ø3.2mm ASSY FDA UDI
FEMALE TREPHINE 8.0MM FDA UDI
PEG DRILL 2.8 mm FDA UDI
Male Long Component for Ø6.4mm Assy FDA UDI
Short Tibial/Humeral Nail Assy Ø5.6mm x 405mm FDA UDI
Short Proximal Long Distal Nail Assy Ø4.8mm x 409mm FDA UDI
FD GUIDE WIRE Ø1.8mm - PACKAGE OF 6 FDA UDI
LON Femoral Nail Assy Ø4.8 mm x 400mm FDA UDI
STERILE MALE SHORT COMPONENT FOR Ø4.0mm ASSY FDA UDI
MALE DRIVER Ø3.2mm FDA UDI
Male Short Component for Ø3.2mm Assy FDA UDI
MALE DRIVER Ø5.6mm FDA UDI
PEG Ø2.0mm x 40mm FDA UDI
LON Tibial/Humeral Assy Ø4.0mm x 330mm FDA UDI
MALE DRIVER Ø4.0mm FDA UDI
Femoral Female Component for Ø5.6mm Assy FDA UDI
STERILE FEMORAL FEMALE COMPONENT FOR Ø4.8mm ASSY FDA UDI
STERILE TIBIA/HUMERAL FEMALE COMPONENT FOR Ø3.2mm ASSY FDA UDI
PEG Ø2.8mm x 40mm FDA UDI
CUTTING WHEEL FOR THE FEMALE COMPONENT CUTTER FDA UDI
COIL-PULLER SHAFT Ø5.6mm FDA UDI
Short Tibial/Humeral Nail Assy Ø4.8mm x 404mm FDA UDI
PEG Ø2.8mm x 20mm FDA UDI
Short Proximal Long Distal Nail Assy Ø3.2 mm FDA UDI
Short Femoral Nail Assy Ø6.4mm x 407mm FDA UDI
PEG Ø2.8mm x 56mm FDA UDI
PEG Ø2.8mm x 60mm FDA UDI
TREPHINE 4.0mm FDA UDI
PEG Ø2.0mm x 44mm FDA UDI
Short Proximal Long Distal Nail Assy Ø4.0mm x 338mm FDA UDI
4.0-6.4 CARTRIDGE FDA UDI
COIL-PULLER SHAFT Ø4.0mm FDA UDI
Long Femoral Nail Assy Ø3.2mm FDA UDI
Femoral Female Component for Ø4.0mm Assy FDA UDI
T8 TORX SCREWDRIVER FDA UDI
PEG Ø2.8mm x 32mm FDA UDI
Male LON Component for Ø5.6mm Assy FDA UDI

Identifiers

Catalog Number
M048-SS-70 FDA UDI
FD-LCP-160 FDA UDI
M032-SS-100-S FDA UDI
PEG-PGD124 FDA UDI
PEG-PGD120 FDA UDI
M048-SS-70-S FDA UDI
F064-SS-S FDA UDI
FD-048(L)-SS FDA UDI
T048-SS-S FDA UDI
M064-SS-150-S FDA UDI
DR156 FDA UDI
FDLON-T048-SS FDA UDI
FD-056(SPL)-SS FDA UDI
F032-SS-S FDA UDI
FTRP108 FDA UDI
PEG-PGD128 FDA UDI
M064-SS-150 FDA UDI
FD-056(SPS)-SS FDA UDI
FD-048(SPL)-SS FDA UDI
G-WIRE 018-PKG6 FDA UDI
FDLON-F048-SS FDA UDI
M040-SS-60-S FDA UDI
MDR132 FDA UDI
M032-SS-50 FDA UDI
MDR156 FDA UDI
FD-PEG-20-040 FDA UDI
FDLON-T040-SS FDA UDI
MDR140 FDA UDI
F056-SS FDA UDI
F048-SS-S FDA UDI
T032-SS-S FDA UDI
FD-PEG-28-040 FDA UDI
FC-WHL100 FDA UDI
MR256-S FDA UDI
FD-048(SPS)-SS FDA UDI
FD-PEG-28-020 FDA UDI
FD-032(SPL)-SS FDA UDI
FD-064(S)-SS FDA UDI
FD-PEG-28-056 FDA UDI
FD-PEG-28-060 FDA UDI
TRP140 FDA UDI
FD-PEG-20-044 FDA UDI
FD-040(SPL)-SS FDA UDI
FRT250 FDA UDI
MR240-S FDA UDI
FD-032(L)-SS FDA UDI
F040-SS FDA UDI
GIN-TRX800 FDA UDI
FD-PEG-28-032 FDA UDI
M056-SS-LON FDA UDI
Primary DI / UDI-DI
07540194014245 EUDAMEDFDA UDI
07540194000132 FDA UDI
07540194012111 FDA UDI
07540194013286 FDA UDI
07540194012548 FDA UDI
07540194012531 FDA UDI
07540194013354 FDA UDI
07540194013224 FDA UDI
07540194000385 FDA UDI
07540194013255 FDA UDI
07540194013415 FDA UDI
07540194006790 FDA UDI
07540194000439 FDA UDI
07540194000460 FDA UDI
07540194013187 FDA UDI
07540194013002 FDA UDI
07540194012555 FDA UDI
07540194000194 FDA UDI
07540194000477 FDA UDI
07540194000408 FDA UDI
07540194014986 FDA UDI
07540194000422 FDA UDI
07540194013323 FDA UDI
07540194006998 FDA UDI
07540194000071 FDA UDI
07540194007087 FDA UDI
07540194017567 FDA UDI
07540194000378 FDA UDI
07540194007025 FDA UDI
07540194000040 FDA UDI
07540194013200 FDA UDI
07540194013231 FDA UDI
07540194017680 FDA UDI
07540194007575 FDA UDI
07540194000415 FDA UDI
07540194017901 FDA UDI
07540194000286 FDA UDI
07540194000514 FDA UDI
07540194017727 FDA UDI
07540194017734 FDA UDI
07540194007605 FDA UDI
07540194017574 FDA UDI
07540194000347 FDA UDI
07540194013040 FDA UDI
07540194007551 FDA UDI
07540194000262 FDA UDI
07540194000026 FDA UDI
07540194012708 FDA UDI
07540194017666 FDA UDI
07540194000170 FDA UDI
Basic UDI-DI
7540194FD-CWQV EUDAMED
510(k) Number
K020885 FDA UDI
K041393 FDA UDI
K211292 FDA UDI
FDA Product Code
HSB FDA UDI
HTW FDA UDI
HWK FDA UDI
LXH FDA UDI
HXX FDA UDI
HXZ FDA UDI
HWB FDA UDI
EMDN Code
L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Arthrodesis intramedullary nail, non-distracting FDA UDI
Orthopaedic bone screw (non-sliding) FDA UDI
Fluted surgical drill bit, reusable FDA UDI
Cannulated surgical drill bit, reusable FDA UDI
Bone trephine, reusable FDA UDI
Orthopaedic guidewire, single-use FDA UDI
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Metal-cutting bur FDA UDI
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Surgical screwdriver, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
888.4540 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDIFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 4.8 Millimeter FDA UDI
Outer Diameter — 1.6 Millimeter FDA UDI
Outer Diameter — 3.2 Millimeter FDA UDI
Outer Diameter — 2.35 Millimeter FDA UDI
Length — 150 Millimeter FDA UDI
Outer Diameter — 1.95 Millimeter FDA UDI
Outer Diameter — 6.4 Millimeter FDA UDI
Length — 409 Millimeter FDA UDI
Lumen/Inner Diameter — 2.2 Millimeter FDA UDI
Length — 350 Millimeter FDA UDI
Outer Diameter — 5.9 Millimeter FDA UDI
Length — 400 Millimeter FDA UDI
Outer Diameter — 5.6 Millimeter FDA UDI
Length — 410 Millimeter FDA UDI
Outer Diameter — 8.10 Millimeter FDA UDI
Outer Diameter — 2.75 Millimeter FDA UDI
Length — 405 Millimeter FDA UDI
Outer Diameter — 1.8 Millimeter FDA UDI
Length — 457 Millimeter FDA UDI
Outer Diameter — 4 Millimeter FDA UDI
Length — 40 Millimeter FDA UDI
Outer Diameter — 2.0 Millimeter FDA UDI
Length — 330 Millimeter FDA UDI
Outer Diameter — 2.8 Millimeter FDA UDI
Lumen/Inner Diameter — 3.67 Millimeter FDA UDI
Length — 404 Millimeter FDA UDI
Length — 20 Millimeter FDA UDI
Length — 202 Millimeter FDA UDI
Length — 407 Millimeter FDA UDI
Length — 56 Millimeter FDA UDI
Length — 60 Millimeter FDA UDI
Lumen/Inner Diameter — 2.54 Millimeter FDA UDI
Length — 44 Millimeter FDA UDI
Length — 338 Millimeter FDA UDI
Lumen/Inner Diameter — 2.6 Millimeter FDA UDI
Length — 32 Millimeter FDA UDI

Category: Bone cutting forceps, reusable

The Fassier-Duval Telescopic IM System by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone cutting forceps, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
OrthoPediatrics Canada ULC
EUDAMED SRN
CA-MF-000013010
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (51)

  • EUDAMED e69a02c0-833d-4463-814d-3265027f7f8e 61 fields · synced Sep 18, 2026
  • FDA UDI d65d1b86-2222-47c8-9baf-70aa401bc5af 38 fields · synced May 27, 2026
  • FDA UDI b27e8165-6cbc-4e15-8b1c-91833cdf385c 38 fields · synced May 27, 2026
  • FDA UDI 208bcd19-2289-4a12-a349-67cf02f25d88 38 fields · synced May 27, 2026
  • FDA UDI 9f9b31ed-e520-4059-a61f-dd4a33fa9c2b 37 fields · synced May 29, 2026
  • FDA UDI afe45197-d79a-461b-bc75-bf2afa2cf0d3 37 fields · synced May 29, 2026
  • FDA UDI 25dec153-4c5a-49fe-8613-5406b9a8956d 38 fields · synced May 29, 2026
  • FDA UDI 76b52d7d-dfe6-48e6-9861-8921bd9eb72b 38 fields · synced May 29, 2026
  • FDA UDI 7c9bd832-1f74-4a9a-aa37-26e8b42be8f5 38 fields · synced May 29, 2026
  • FDA UDI 53660ed0-0197-40dd-a306-482bbc3e7ccc 38 fields · synced May 29, 2026
  • FDA UDI f7c823bc-439c-4d7e-80cd-4accf901cbaf 38 fields · synced May 29, 2026
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  • FDA UDI 0b72909c-095b-4c3f-99b4-8ada65fae33e 37 fields · synced May 30, 2026
  • FDA UDI 10232e1d-9b35-4908-abbe-64b04a8bb310 38 fields · synced May 30, 2026
  • FDA UDI b07bd295-97c5-4a97-bc54-a73512fa0fba 35 fields · synced May 30, 2026
  • FDA UDI 63dcf909-b6c6-4840-b9cf-956a180e0f2d 37 fields · synced May 30, 2026
  • FDA UDI 087a24aa-5c74-40aa-9c56-c43a099192e0 38 fields · synced May 30, 2026
  • FDA UDI 4a3351dd-4115-469c-a1b9-0d04798cda5d 38 fields · synced May 30, 2026
  • FDA UDI 7b393819-c1d5-43c9-a903-7a9d130e3975 36 fields · synced May 30, 2026
  • FDA UDI 0f6714ce-d1be-40f2-a392-0746a33105d8 37 fields · synced May 30, 2026
  • FDA UDI ec4646a2-80b5-415f-ae49-b4fcfd7d68f7 38 fields · synced May 30, 2026