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Trephine 11mm ID

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 10-092-000

by Symmetry Medical Manufacturing, Inc.

Identity

Trade Name
Trephine 16.5mm ID FDA UDI
Generic Name
Bone trephine, reusable FDA UDI
Device Name
Trephine 11mm ID EUDAMED
Trephine 16.5mm ID FDA UDI
Model / Reference
10-092-000 EUDAMEDFDA UDI
Description
Trephine 16.5mm ID FDA UDI

Identifiers

Catalog Number
2709-05-165;00-9986-040-25 FDA UDI
Primary DI / UDI-DI
00847538001600 EUDAMEDFDA UDI
Basic UDI-DI
08475380141472D EUDAMED
Direct Marketing DI
00847538001600 EUDAMED
FDA Product Code
HWK FDA UDI
EMDN Code
L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMED
GMDN Term
Bone trephine, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Trephine 11mm ID by Symmetry Medical Manufacturing, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Symmetry Medical Manufacturing, Inc.
EUDAMED SRN
US-MF-000025394
Authorised Representative
SYMMETRY MEDICAL POLYVAC FR-AR-000003187

Sources (2)

  • EUDAMED a83d0893-23fc-46fe-819f-33b1ab16e9bf 61 fields · synced Jun 20, 2026
  • FDA UDI 7f2ed14c-09dc-4418-a213-df3e632181f3 34 fields · synced May 30, 2026