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Coe Syringe 159001

by Gc America Inc. 2 variants

Coe Syringe 159001 is a Class I device made by Gc America Inc., listed in FDA GUDID since 10 Feb 2017 (UDI-DI D6581590011), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD6581590011 UDI-DI Date10 Feb 2017ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Coe Syringe
Generic name
Dental impression material syringe, reusable
Model / Ref / Catalog
159001
Primary DI / UDI-DI
D6581590011
FDA product code
EID
GMDN term
Dental impression material syringe, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)