Identity
- Trade Name
- Dental City FDA UDI
- Generic Name
- Implantable-device infection control barrier FDA UDI
- Device Name
- Dental City Barrier Film 4X6 Pink (with dispenser box) FDA UDI
- Model / Reference
- 33-353PK FDA UDI
- Description
- Dental City Barrier Film 4X6 Pink (with dispenser box) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D77133353PK1 FDA UDI
- FDA Product Code
- IWX FDA UDI
- GMDN Term
- Implantable-device infection control barrier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Implantable-device infection control barrier
Dental City by Icp, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PlastCare — PROGUARD HEALTH INC. · Class I
- PlastCare — PROGUARD HEALTH INC. · Class I
- PlastCare — PROGUARD HEALTH INC. · Class I
- PlastCare — PROGUARD HEALTH INC. · Class I
- Dental City — ICP, 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
- Icp, Inc.
Sources (1)
- FDA UDI 708a0144-c184-4c12-ba79-ef1efd70a3a3 33 fields · synced Jun 8, 2026