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PUMA-G System™ 0010080

by Coaptech, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10860312001532 UDI-DI Date16 May 2024ListedStatusListed GUDID: not 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  • Withdrawn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 magnet
Model / Ref / Catalog
0010080, 0010090
Primary DI / UDI-DI
10860312001532
FDA Product Code
KGC
GMDN Term
Ultrasound-guided gastrostomy system magnet
Device Class
Class II
Regulation Number
876.5980
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Coaptech, Inc.

See all devices from Coaptech, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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