Identity
- Trade Name
- AuraPrene FDA UDI
- Generic Name
- Polychloroprene examination/treatment glove, non-powdered FDA UDI
- Device Name
- AuraPrene DDS-305 Size X-Large Inner Pack - 100 FDA UDI
- Model / Reference
- DDS-305 FDA UDI
- Description
- AuraPrene DDS-305 Size X-Large Inner Pack - 100 FDA UDI
Identifiers
- Catalog Number
- DDS-305 FDA UDI
- Primary DI / UDI-DI
- 00858711006350 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Polychloroprene examination/treatment glove, non-powdered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polychloroprene examination/treatment glove, non-powdered
AuraPrene by American Medical & Dental Supplies Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- American Medical & Dental Supplies Inc
Sources (1)
- FDA UDI 1eea52c5-7f7d-4743-b385-f311271937be 34 fields · synced Jun 8, 2026