Identity
- Trade Name
- Unipack FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Oral Camera Cover Pro-Den/Dent-X/Pro-Scope 1000 FDA UDI
- Model / Reference
- UBC-820831 FDA UDI
- Description
- Oral Camera Cover Pro-Den/Dent-X/Pro-Scope 1000 FDA UDI
Identifiers
- Catalog Number
- UBC-820831 FDA UDI
- Primary DI / UDI-DI
- D784UBC8208311 FDA UDI
- FDA Product Code
- NRD FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
No
FDA UDI
Category: Medical equipment/instrument drape, single-use
Unipack by Unipack Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Probe Cover — Advance Medical Designs, Inc. · Class II
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
- Unipack Medical Corporation
Sources (1)
- FDA UDI 2fbefe8f-ff56-48f0-834d-1b37f6f2d161 35 fields · synced Jun 1, 2026