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Cook G61355

by Cook Incorporated

Cook G61355 (SDN-18-9.0-UM) is a Class II device made by Cook Incorporated, listed in FDA GUDID since 22 Oct 2026 (UDI-DI 00827002613553), registry data as of 2 Nov 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00827002613553 UDI-DI Date22 Oct 2026ListedStatusListed 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  • Withdrawn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
Hypodermic needle, single-use
Model / Ref / Catalog
G61355, SDN-18-9.0-UM
Description
Percutaneous Entry Thinwall Needle One-Part
Primary DI / UDI-DI
00827002613553
FDA product code
JOL
GMDN term
Hypodermic needle, single-use
Device class
Class II
Regulation number
880.6740
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)