Identity
- Trade Name
- NAMIC FDA UDI
- Generic Name
- Stopcock FDA UDI
- Device Name
- Y-ADAPTOR,LG.BORE,FINE THREAD W/10" FLEXCIL EXT.-OEM FDA UDI
- Model / Reference
- 81400124 FDA UDI
- Description
- Y-ADAPTOR,LG.BORE,FINE THREAD W/10" FLEXCIL EXT.-OEM FDA UDI
Identifiers
- Primary DI / UDI-DI
- H965814001240 FDA UDI
- 510(k) Number
- K900652 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Stopcock FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.113 Inch FDA UDI
Category: Stopcock
Namic by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Stopcock.
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Cleared under the same submission
K900652 also covers:
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, INC.
- NAMIC — NAVILYST MEDICAL, 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
- Angiodynamics, Inc.
Sources (1)
- FDA UDI 4d042f88-f79e-4ed6-a822-bd90664eb9c5 36 fields · synced Jun 6, 2026