Identity
- Trade Name
- CRW® FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Apuzzo Stereo Drape FDA UDI
- Model / Reference
- ASD1 FDA UDI
- Description
- Apuzzo Stereo Drape FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780167327 FDA UDI
- 510(k) Number
- K944463 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical equipment/instrument drape, single-use
Crw® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medical equipment/instrument drape, single-use.
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Cleared under the same submission
K944463 also covers:
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
- CRW® — Integra Lifesciences Corp.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 9eebcf9e-a6fe-41dc-93af-a8d71a82ad44 35 fields · synced May 30, 2026