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Cook G48527

by Cook Incorporated

Cook G48527 (J-FB-100) is a Class I device made by Cook Incorporated, listed in FDA GUDID since 2 Oct 2020 (UDI-DI 00827002485273), 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 Number00827002485273 UDI-DI Date2 Oct 2020ListedStatusListed 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  • Withdrawn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
Cook
Generic name
Torque manipulation device
Model / Ref / Catalog
G48527, J-FB-100
Primary DI / UDI-DI
00827002485273
FDA product code
GED
GMDN term
Torque manipulation device
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)