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MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref SSS-LP-60-T
Identity
- Trade Name
- MEDRAD® Stellant Syringe Kits EUDAMEDMEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- MEDRAD® Stellant Syringe Kits EUDAMEDASSY,TUBE SET,LPCT,TC,STLNT,MC,CORE2 (87622770) FDA UDI
- Model / Reference
- SSS-LP-60-T EUDAMEDFDA UDI
- Description
- ASSY,TUBE SET,LPCT,TC,STLNT,MC,CORE2 (87622770) FDA UDI
Identifiers
- Catalog Number
- SSS-LP-60-T FDA UDI
- Primary DI / UDI-DI
- 00616258024813 EUDAMEDFDA UDI
- Basic UDI-DI
- 0616258TFCN-0050Q5 EUDAMED
- 510(k) Number
- K182273 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
- GMDN Term
- Angiographic syringe FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED
Cleared under the same submission
K182273 also covers:
- Imaging System Interface - ISI2 Module — Bayer Medical Care Inc.
- Low Pressure Connector Tubing Integral “T” with Check Valve — Bayer Medical Care Inc.
- MEDRAD® Stellant Heat Maintainer — Bayer Medical Care Inc.
- MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube — Bayer Medical Care Inc.
- MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube — 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 |
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Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (2)
- FDA UDI c3e6144d-ee29-40f0-9b59-84fc275581fd 38 fields · synced Oct 6, 2026
- EUDAMED c72f16fd-7fb4-438a-a6ac-9ac054e5cf25 61 fields · synced Aug 2, 2026