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Batrik SaveFace Disposable Shoe Covers\Dispenser box
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Batrik SaveFace Disposable Shoe Covers\Dispenser box FDA UDI
- Generic Name
- Shoe cover, conductive, non-sterile FDA UDI
- Device Name
- SaveFace Shoe Covers, anti skid, XL size, Blue FDA UDI
- Model / Reference
- SF-SC02XL FDA UDI
- Description
- SaveFace Shoe Covers, anti skid, XL size, Blue FDA UDI
Identifiers
- Catalog Number
- SF-SC02XL FDA UDI
- Primary DI / UDI-DI
- 00690521017047 FDA UDI
- FDA Product Code
- FXP FDA UDI
- GMDN Term
- Shoe cover, conductive, non-sterile 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Shoe cover, conductive, non-sterile
Batrik SaveFace Disposable Shoe Covers\Dispenser box by Batrik Medical Manufacturing Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Shoe cover, conductive, non-sterile.
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- Precept® — Precept Medical Products, Inc. · Class I
- Precept® — Precept Medical Products, Inc. · Class I
- Critical Cover — ALPHAPROTECH, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc
Sources (2)
- FDA UDI 6988814b-e6e2-4d87-8887-148eb9fea295 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026