Identity
- Trade Name
- Essentials by 3D Dental FDA UDI
- Generic Name
- Polychloroprene examination/treatment glove, non-powdered FDA UDI
- Device Name
- Luxaprene Chloroprene Glove powder free Box/100 Small Case/10 FDA UDI
- Model / Reference
- CG100-S-CS FDA UDI
- Description
- Luxaprene Chloroprene Glove powder free Box/100 Small Case/10 FDA UDI
Identifiers
- Catalog Number
- CG100-S-CS FDA UDI
- Primary DI / UDI-DI
- 00810126503961 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
- Not 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
No
FDA UDI
Essentials by 3D Dental by 3d Dental Designs And Development, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- 3d Dental Designs And Development, Llc
Sources (1)
- FDA UDI c0b44e03-8fe4-4d88-a2f6-b9122f1418d0 35 fields · synced May 31, 2026