← Back to catalogue
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Device Name
- Stellant 60" low pressure connector tube with prime tube (ASSY,FNAL,LPCT,W/PTUBE,SSS-LP-60,FLEX,MC) (86310198) FDA UDI
- Model / Reference
- SSS-LP-60 FDA UDI
- Description
- Stellant 60" low pressure connector tube with prime tube (ASSY,FNAL,LPCT,W/PTUBE,SSS-LP-60,FLEX,MC) (86310198) FDA UDI
Identifiers
- Catalog Number
- SSS-LP-60 FDA UDI
- Primary DI / UDI-DI
- 00616258021164 FDA UDI
- 510(k) Number
- K173773 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Radiographic procedure tubing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiographic procedure tubing
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Radiographic procedure tubing.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- High Pressure Tubing, Keep™ — Merit Medical Systems, Inc. · Class II
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd. · Class II
- Coeur Acist — Coeur, Inc. · Class II
- Antmed — ShenZhen Antmed Co., Ltd · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Solution Transfer Device — Bracco Diagnostics Inc. · Class II
Cleared under the same submission
K173773 also covers:
- MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade) — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI e734abab-9636-4024-b48e-ef649c2ff66f 36 fields · synced Jun 9, 2026