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PUMA-G System™ 0010440

by Coaptech, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850026037227 UDI-DI Date13 Feb 2024ListedStatusListed 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  • Withdrawn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
PUMA-G System™
Generic Name
Ultrasound-guided gastrostomy system catheter
Model / Ref / Catalog
0010440, 0010450-0X, 0010460
Description
Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
Primary DI / UDI-DI
00850026037227
FDA Product Code
KGC
GMDN Term
Ultrasound-guided gastrostomy system catheter
Device Class
Class II
Regulation Number
876.5980
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Ultrasound-guided gastrostomy system catheter

Other devices from Coaptech, Inc.

See all devices from Coaptech, Inc. →

Properties

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

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No