Identity
- Trade Name
- AD Surgical FDA UDI
- Generic Name
- Surgical dressing/drape kit, single-use FDA UDI
- Device Name
- Half Drape Sterile, Absorbent, Impervious PE/PP. 44"x60". FDA UDI
- Model / Reference
- A400-HFD FDA UDI
- Description
- Half Drape Sterile, Absorbent, Impervious PE/PP. 44"x60". FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814639022063 FDA UDI
- FDA Product Code
- PUI FDA UDI
- GMDN Term
- Surgical dressing/drape kit, single-use 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical dressing/drape kit, single-use
A comprehensive 2-3 paragraph SEO description written in clear, natural language. Labeling contains important information about the device's design and features.
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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
- Applied Dental, Inc.
Sources (1)
- FDA UDI 48c3b639-ed27-4dc2-ba5d-7f9f6585b5b8 34 fields · synced Jun 27, 2026