Identity
- Trade Name
- Busse Hospital Disposables FDA UDI
- Generic Name
- Visitor hygiene coverall FDA UDI
- Device Name
- Coveralls, Extra Large, white, zipper front, with elastic cuffs FDA UDI
- Model / Reference
- 215 FDA UDI
- Description
- Coveralls, Extra Large, white, zipper front, with elastic cuffs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10849233003917 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Visitor hygiene coverall FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- Not 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
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
Busse Hospital Disposables by Robert Busse & Co., Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Robert Busse & Co., Inc.
Sources (1)
- FDA UDI 15224e8c-60a8-4728-aa6c-3ba09c17b151 35 fields · synced Jun 1, 2026