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MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube FDA UDI
- Generic Name
- Angiographic syringe FDA UDIRadiographic procedure tubing FDA UDI
- Device Name
- Stellant 60" low pressure connector tube with prime tube (CT - 60" CONNECTOR TUBING, PT, SSS-LP-60) (60729024) FDA UDI"Stellant 60"" low pressure connector tube with prime tube (ASSY,FNL,LPCT,W/PRIME,SSS-LP-60,MC,JA) (84197009)" FDA UDI
- Model / Reference
- SSS-LP-60 FDA UDI
- Description
- Stellant 60" low pressure connector tube with prime tube (CT - 60" CONNECTOR TUBING, PT, SSS-LP-60) (60729024) FDA UDI"Stellant 60"" low pressure connector tube with prime tube (ASSY,FNL,LPCT,W/PRIME,SSS-LP-60,MC,JA) (84197009)" FDA UDI
Identifiers
- Catalog Number
- SSS-LP-60 FDA UDI
- Primary DI / UDI-DI
- 00616258005270 FDA UDI00616258007168 FDA UDI
- 510(k) Number
- K023183 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Angiographic syringe FDA UDIRadiographic 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: Angiographic syringe
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube by Bayer Medical Care Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Angiographic syringe.
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Cleared under the same submission
K023183 also covers:
- Low Pressure Connector Tubing Integral “T” with Check Valve — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bayer Medical Care Inc.
Sources (3)
- FDA UDI 03d98ce2-d8b5-4872-8076-d7801cd82f36 36 fields · synced Jun 15, 2026
- FDA UDI 0efbf270-16cd-465d-88e6-fdc9392c94bd 36 fields · synced May 25, 2026
- EUDAMED 1 fields · synced Jun 15, 2026