Identity
- Trade Name
- COMPLETE DENTAL SUPPLIES FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Isolation Gown, Nylon Knitted Cuffs 30g PP Blue 10 pcs/bag FDA UDI
- Model / Reference
- 20613-CDS FDA UDI
- Description
- Isolation Gown, Nylon Knitted Cuffs 30g PP Blue 10 pcs/bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850055627062 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Isolation gown, single-use 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
No
FDA UDI
Category: Isolation gown, single-use
Complete Dental Supplies by Complete Dental Supplies LLC — 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
- Complete Dental Supplies LLC
Sources (1)
- FDA UDI bcfb9af9-c2e7-4be3-9394-75aa80af887a 33 fields · synced Jun 8, 2026