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MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- Twist & Go Syringe Kit, 150 ML (ANGIO - ARTERION, TWIST & GO150ML SYR w/QFT, MC) (60766817) FDA UDI
- Model / Reference
- TAG 150 SYR FDA UDI
- Description
- Twist & Go Syringe Kit, 150 ML (ANGIO - ARTERION, TWIST & GO150ML SYR w/QFT, MC) (60766817) FDA UDI
Identifiers
- Catalog Number
- TAG 150 SYR FDA UDI
- Primary DI / UDI-DI
- 00616258006987 FDA UDI
- 510(k) Number
- K131517 FDA UDI
- FDA Product Code
- FPK FDA UDI
- GMDN Term
- Angiographic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
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
Category: Angiographic syringe
MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill 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
K131517 also covers:
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill Tube — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 120cm (48in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 120cm (48in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 120cm (48in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) — Bayer Medical Care Inc.
- MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) — 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 (2)
- FDA UDI 6bd476d6-051d-4832-b5b8-8934da5e5140 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026