Identity
- Trade Name
- BARRIER FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- 5 x 28 Instrument / equipment drape, single-use, non-sterile x-ray sox FDA UDI
- Model / Reference
- BB-0528X FDA UDI
- Description
- 5 x 28 Instrument / equipment drape, single-use, non-sterile x-ray sox FDA UDI
Identifiers
- Catalog Number
- BB-0528X-1 FDA UDI
- Primary DI / UDI-DI
- H816BB0528X1 FDA UDI
- 510(k) Number
- K922175 FDA UDI
- FDA Product Code
- KLC FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6250 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument/equipment drape, single-use, non-sterile
Barrier by Certol International, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Certol International, Llc
Sources (1)
- FDA UDI a12db8a1-d5e4-4832-a7d1-7bedd5473fb7 35 fields · synced May 30, 2026