Identity
- Trade Name
- OR Specific FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- One-Piece Drape, Heavy Duty, Sterile, for Big Case Back Table 429 FDA UDI
- Model / Reference
- 420-HE-S FDA UDI
- Description
- One-Piece Drape, Heavy Duty, Sterile, for Big Case Back Table 429 FDA UDI
Identifiers
- Catalog Number
- 420-HE-S FDA UDI
- Primary DI / UDI-DI
- 00841027100171 FDA UDI
- FDA Product Code
- PUI FDA UDI
- GMDN Term
- Patient surgical drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
OR Specific by Or Specific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Or Specific, Inc.
Sources (1)
- FDA UDI 839d457d-24c3-4ee2-9e4e-d6c1f5d35322 36 fields · synced Jun 6, 2026