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Surgical Instrument C8P.07020

by OSTEONIC CO., Ltd.

Surgical Instrument C8P.07020 is a Class I device made by OSTEONIC CO., Ltd., listed in FDA GUDID since 25 Jun 2025 (UDI-DI 08809416068626), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809416068626 UDI-DI Date25 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Surgical Instrument
Generic name
Manual orthopaedic bender, reusable
Model / reference
C8P.07020
Primary DI / UDI-DI
08809416068626
FDA product code
HXP
GMDN term
Manual orthopaedic bender, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)