Identity
- Trade Name
- Precept® FDA UDI
- Generic Name
- Shoe cover, conductive, non-sterile FDA UDI
- Device Name
- Nonwoven Shoe Covers FDA UDI
- Model / Reference
- 4223 FDA UDI
- Description
- Nonwoven Shoe Covers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20814707020971 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
Yes
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
Precept® by Precept Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Precept® — Precept Medical Products, Inc. · Class I
- Precept® — Precept Medical Products, Inc. · Class I
- Precept® — Precept Medical Products, Inc. · Class I
- Precept® — Precept Medical Products, Inc. · 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
- Precept Medical Products, Inc.
Sources (1)
- FDA UDI 4f793aea-7eb3-445f-aab3-8cab5599e9f8 34 fields · synced May 30, 2026