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MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- ASSY,TUBE SET,SPECTRIS,96”,MC,WLD (86653516) FDA UDI
- Model / Reference
- SIT 96V FDA UDI
- Description
- ASSY,TUBE SET,SPECTRIS,96”,MC,WLD (86653516) FDA UDI
Identifiers
- Catalog Number
- SIT 96V FDA UDI
- Primary DI / UDI-DI
- 00616258021836 FDA UDI
- 510(k) Number
- K980417 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Angiographic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 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
MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Angiographic syringe.
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- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Inject8™ — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K980417 also covers:
- Disposable MRI Kit A Disposable Kit for use with the 65/65 MR Injector from Baye — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Disposable MRI Kit with Check Valve — Bayer Medical Care Inc.
- Female - Female Adapter — Bayer Medical Care Inc.
- Female - Female Adapter — Bayer Medical Care Inc.
- Female - Female Adapter — 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 7ef83f7f-d1f6-4858-9676-f70c8d2d8c96 36 fields · synced Jun 9, 2026