Identity
- Trade Name
- Safti Cuff FDA UDI
- Generic Name
- Enema tip, single-use FDA UDI
- Device Name
- Safticuff SL Airway FDA UDI
- Model / Reference
- 900911 FDA UDI
- Description
- Safticuff SL Airway FDA UDI
Identifiers
- Catalog Number
- 900911 FDA UDI
- Primary DI / UDI-DI
- 10815112020917 FDA UDI
- FDA Product Code
- FGD FDA UDI
- GMDN Term
- Enema tip, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
Yes
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 48 French FDA UDI
Category: Enema tip, single-use
Safti Cuff by Bracco Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Enema tip, single-use.
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- Rounded Flexi Tip Adult Enema Tip — Bracco Diagnostics Inc. · Class II
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- FLEXI-STOME Cone Colostomy Tip — Bracco Diagnostics Inc. · 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
- Bracco Diagnostics Inc.
Sources (1)
- FDA UDI fc42ebab-ef24-45aa-9de8-f8c59402842a 36 fields · synced May 30, 2026