Identity
- Trade Name
- Dornier MedTech FDA UDI
- Generic Name
- Surgical tissue/fluid collection bag, non-sterile FDA UDI
- Device Name
- Non- sterile flexible disposable drain bag with hose adapters for use on Dornier Genesis Urological Table FDA UDI
- Model / Reference
- Dornier Genesis Urology Drain Bag FDA UDI
- Description
- Non- sterile flexible disposable drain bag with hose adapters for use on Dornier Genesis Urological Table FDA UDI
Identifiers
- Catalog Number
- 10501000 FDA UDI
- Primary DI / UDI-DI
- 00810116023035 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Surgical tissue/fluid collection bag, non-sterile 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
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
Category: Surgical tissue/fluid collection bag, non-sterile
Dornier MedTech by Dornier MedTech America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Dornier MedTech America, Inc.
Sources (1)
- FDA UDI 11f05c49-a834-4fdd-8e44-ce4e1543c05f 34 fields · synced Jun 9, 2026