Identity
- Trade Name
- TYTEK TRAUMA BANDAGE FDA UDI
- Generic Name
- First aid absorbent pad/bandage FDA UDI
- Device Name
- Abdominal Trauma Bandage FDA UDI
- Model / Reference
- TM-212 FDA UDI
- Description
- Abdominal Trauma Bandage FDA UDI
Identifiers
- Catalog Number
- TM-212 FDA UDI
- Primary DI / UDI-DI
- 00855204008082 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- First aid absorbent pad/bandage FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: First aid absorbent pad/bandage
Tytek Trauma Bandage by Tytek Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as First aid absorbent pad/bandage.
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- FCP Bandage — FIRST CARE PRODUCTS LTD · Class I
- Medi-First Plus Sterile Gauze Pads 2 x 2 (25 count) — Medique Products · Class I
- H-Bandage Compression Dressing - Rolled — H & H Medical Corporation · Class I
- EMSRUN — Anji Hengfeng Sanitary Material Co., Ltd · Class I
- RHINO RESCUE — Wuxi Emsrun Technology Co., Ltd. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Tytek Medical Inc
Sources (1)
- FDA UDI 352d913e-cee5-42b3-b68b-04d7e78e2d2f 34 fields · synced Jun 8, 2026