Identity
- Trade Name
- Tex-Care Medical FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- 8X38 IMP STKT FDA UDI
- Model / Reference
- 81160-838 FDA UDI
- Description
- 8X38 IMP STKT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00632195000345 FDA UDI
- 510(k) Number
- K955749 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Patient surgical drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient surgical drape, single-use
Tex-Care Medical by Flynt/Amtex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K955749 also covers:
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
- Tex-Care Medical — Flynt/Amtex, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Flynt/Amtex, Inc.
Sources (1)
- FDA UDI 1a456521-0011-4ab2-a3b1-44827b60cdcd 34 fields · synced May 31, 2026