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SQ.line®

by Aesculap AG 105 variants

Ref FO516NR, ND109NR, FO550NR, FK324NR, FK644NR, FL408NR, FL441NR, FL416NR, FL922NR, ND584NR, FO641NR, FK423NR

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number403923900000169233 Basic UDI-DI Date18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046955285747 UDI-DI Date20 May 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Orthopaedic joint/limb rongeur
Orthopaedic chisel
Orthopaedic osteotome
Bone curette, reusable
Surgical tamp, reusable
Bone file/rasp, manual, reusable
Device Name
Bone rongeur
Chisel / osteotome
Raspatorien
Spoon
Tamper
Model / Ref / Catalog
FO516NR, FL416NR, ND109NR, FL441NR, FO550NR, FK644NR, ND584NR, FL922NR, FK423NR, FO641NR, FK324NR, FL408NR
Primary DI / UDI-DI
04046955285747, 04046955288809, 04046955289424, 04046955284917, 04046955282579, 04046955287925, 04046955286096, 04046955289158, 04046955287819, 04046955285808, 04046955286225, 04046955288700
Basic UDI-DI
403923900000169233, 403923900000044325, 40392390000003932F, 403923900000040823, 4039239000000406ZU, 403923900000169335
Direct Marketing DI
04046955285747
04046955289424
04046955282579
04046955286225
04046955287925
04046955288700
04046955284917
04046955288809
04046955289158
04046955286096
04046955285808
04046955287819
FDA Product Code
HTX, GDH, HWM, HCY, HXG, HTR, HTD, GEG
EMDN Code
L091302, L090401, L091201, L0901, L090403, L0999
GMDN Term
Orthopaedic joint/limb rongeur
Orthopaedic chisel
Orthopaedic osteotome
Bone curette, reusable
Surgical tamp, reusable
Bone file/rasp, manual, reusable
Device Class
Class I
Regulation Number
888.4540, 878.4800, 884.4530
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No