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Na Om-Comp-Bfly-2PK

by GMDASZ manufacturing Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number06970341670528 UDI-DI Date24 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Transcutaneous electrical stimulation electrode, reusable
Model / Reference
OM-COMP-BFLY-2PK
Primary DI / UDI-DI
06970341670528
510(k) Number
FDA Product Code
GXY
GMDN Term
Transcutaneous electrical stimulation electrode, reusable
Device Class
Class II
Regulation Number
882.1320
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K160138)

Show all (12)

Other devices from GMDASZ manufacturing Co., Ltd.

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Properties

  • Prescription Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No