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Tisuthes TPS02

by Shanghai Suokang Medical Implants 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 Number06970461300022 UDI-DI Date22 Jul 2026ListedStatusListed 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  • Withdrawn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

Trade Name
Tisuthes
Generic Name
PTFE/carbon-fibre craniofacial tissue reconstructive material
Model / Reference
TPS02
Primary DI / UDI-DI
06970461300022
510(k) Number
FDA Product Code
OWR, FTL
GMDN Term
PTFE/carbon-fibre craniofacial tissue reconstructive material
Device Class
Class II
Regulation Number
878.3300
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K201153)

Show all (12)

Other devices from Shanghai Suokang Medical Implants Co., Ltd.

See all devices from Shanghai Suokang Medical Implants Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No