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MEDRAD® Stellant Sterile Disposable Syringe
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref SDS-CTP-QFT
Identity
- Trade Name
- MEDRAD® Stellant Syringe Kits EUDAMEDMEDRAD® Stellant Sterile Disposable Syringe FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- MEDRAD® Stellant Syringe Kits EUDAMEDSTLNT,KIT,SYR,CT,DUAL,TCON,QFT,MC,CORE (87622991) FDA UDI
- Model / Reference
- SDS-CTP-QFT EUDAMEDFDA UDI
- Description
- STLNT,KIT,SYR,CT,DUAL,TCON,QFT,MC,CORE (87622991) FDA UDI
Identifiers
- Catalog Number
- SDS-CTP-QFT FDA UDI
- Primary DI / UDI-DI
- 00616258024585 EUDAMEDFDA UDI
- Basic UDI-DI
- 0616258TFCN-0050Q5 EUDAMED
- 510(k) Number
- K023183 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE 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
Yes
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 Sterile Disposable Syringe by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 (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 8935468f-edab-419c-bbdc-7c7f5150cfe3 38 fields · synced Oct 6, 2026
- EUDAMED 5dcbe1f1-0efc-40a2-a802-31ec544ad9f6 61 fields · synced Jul 29, 2026