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Talee PostOp Talee PostOp w/G2-Bi-Valve Opening

by Invent Medical USA, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860015811110 UDI-DI Date28 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Talee PostOp
Generic Name
Cranial orthosis
Model / Reference
Talee PostOp w/G2-Bi-Valve Opening
Primary DI / UDI-DI
00860015811110
510(k) Number
FDA Product Code
MVA, OAN
GMDN Term
Cranial orthosis
Device Class
Class II
Regulation Number
882.5970
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K230444)

Other devices from Invent Medical USA, LLC

See all devices from Invent Medical USA, LLC →

Properties

  • Single Use
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (10)

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