Identity
- Trade Name
- Clik-FIX FDA UDI
- Generic Name
- Urinary catheter holder, sterile FDA UDI
- Device Name
- Foley drainage tube securement device FDA UDI
- Model / Reference
- DTS-1073 FDA UDI
- Description
- Foley drainage tube securement device FDA UDI
Identifiers
- Catalog Number
- DTS-1073 FDA UDI
- Primary DI / UDI-DI
- 00850933007276 FDA UDI
- FDA Product Code
- EYJ FDA UDI
- GMDN Term
- Urinary catheter holder, sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5130 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: Urinary catheter holder, sterile
Clik-FIX by Starboard Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urinary catheter holder, sterile.
- Positioning System — UC-CARE LTD · Class II
- Warming System-catheter — UC-CARE LTD · Class II
- Clik-FIX — Starboard Medical, Inc. · Class I
- Clik-FIX — Starboard Medical, Inc. · Class I
- Clik-FIX — Starboard Medical, Inc. · Class I
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
- Starboard Medical, Inc.
Sources (1)
- FDA UDI 34a81ed3-7fff-4ed5-b1c5-15bb43090ec7 34 fields · synced May 30, 2026