Identity
- Trade Name
- Quala FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- Quala Cover Film Clear 4X6 FDA UDI
- Model / Reference
- 200-370-C FDA UDI
- Description
- Quala Cover Film Clear 4X6 FDA UDI
Identifiers
- Catalog Number
- 200-370-C FDA UDI
- Primary DI / UDI-DI
- D023200370C1 FDA UDI
- 510(k) Number
- K960352 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Yes
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
Yes
FDA UDI
Category: Instrument/equipment drape, single-use, non-sterile
Quala by National Distribution & Contracting, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K960352 also covers:
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
- Allrap Protective Barriers — METREX RESEARCH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- National Distribution & Contracting, Inc.
Sources (1)
- FDA UDI 60a16d91-709d-43a2-8d72-8ab556387823 36 fields · synced May 30, 2026