Identity
- Trade Name
- Encompass FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- COVER ARM BOARD FDA UDI
- Model / Reference
- CD0963 FDA UDI
- Description
- COVER ARM BOARD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00609953287843 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Patient surgical drape, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Patient surgical drape, reusable
Encompass by Encompass Group, L.L.C. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient surgical drape, reusable.
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Lac-Mac — Lac Mac, Ltd. · Class II
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC. · Class II
- Fenestrated Heart Drape — STANDARD TEXTILE CO., INC. · Class II
- ComPel Surgical Drape — STANDARD TEXTILE CO., INC. · Class II
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
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
- Encompass Group, L.L.C.
Sources (1)
- FDA UDI 5480ae1e-05c2-4d8e-8e2b-1017a7211d7f 34 fields · synced May 30, 2026