Identity
- Trade Name
- OPERATING-ROOM SHOE COVER FDA UDI
- Generic Name
- Medical shoe FDA UDI
- Device Name
- OPERATING-ROOM SHOE COVER, PROTECT WORKSHOES FROM ACCIDENTAL BLOOD OR BODY FLUID SPILLS IN THE OR FDA UDI
- Model / Reference
- 28024 FDA UDI
- Description
- OPERATING-ROOM SHOE COVER, PROTECT WORKSHOES FROM ACCIDENTAL BLOOD OR BODY FLUID SPILLS IN THE OR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950471300076 FDA UDI
- FDA Product Code
- BWP FDA UDI
- GMDN Term
- Medical shoe FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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
Yes
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: Medical shoe
Operating-Room Shoe Cover by Hangzhou A-Tek Medical & Textiles Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical shoe.
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
- Hangzhou A-Tek Medical & Textiles Co., Ltd.
Sources (1)
- FDA UDI c0d1077d-4a54-4e59-ac50-bb8a4fdbd6fb 33 fields · synced May 30, 2026