Skip to content

Sterling

by Conmed Corporation 13 variants

Ref 9761A, H9101RH, C9944A, H9111, 55SPH-EL-RH, C9912, H9118, H9103RH, 40VAL-ST-FH, H9112, MH9111, H9102, H9121RH, EL9111RH, DPS-C009, C9283, H9122, C9911

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

CE MDD

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/MDD EUDAMED NumberB-10845854017258 Basic UDI-DI Date9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845854017258 UDI-DI Date24 Sep 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Sterling EUDAMEDGUDID
Sterling Extrasharp Ultrafrr EUDAMED
STERLING UltraFRR GUDID
Generic Name
Orthopaedic bur, single-use
Arthroscopic shaver system blade, single-use
Device Name
Orthopedic, Non-active, Shaver Blade, Hub Sterling
Orthopedic, Non-active, Shaver Bur, Sterling
Orthopedic, Non-active, Shaver Blade, Ultra
Model / Ref / Catalog
9761A, H9101RH, C9944A, H9111, 55SPH-EL-RH, C9912, H9118, H9103RH, 40VAL-ST-FH, H9112, MH9111, H9102, H9121RH, EL9111RH, DPS-C009, C9283, H9122, C9911
Primary DI / UDI-DI
10845854017258, 10845854029626, 10845854021712, 10845854018088, 20845854019044, 10845854018125, 10845854017333, 10845854018590, 10845854013373, 10845854017678, 10845854017432, 10845854018071, 10845854029657, 20845854018658, 10845854041970, 10845854017388, 10845854017760, 10845854017722
Basic UDI-DI
B-10845854017258, B-10845854029626, B-10845854021712, B-10845854018088, B-20845854019044, B-10845854018125, B-10845854017333, B-10845854018590, B-10845854013373, B-10845854017678, B-10845854017432, B-10845854018071, B-10845854029657, B-20845854018658, B-10845854041970, B-10845854017388, B-10845854017760, B-10845854017722
FDA Product Code
GFF, GFA
EMDN Code
K030203, K030204
GMDN Term
Orthopaedic bur, single-use
Arthroscopic shaver system blade, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4820
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 6 Millimeter
Outer Diameter — 4 Millimeter
Outer Diameter — 5 Millimeter
Outer Diameter — 4.5 Millimeter
Outer Diameter — 5.5 Millimeter
Length — 19 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: 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
  • Manufacturing Date: No