Identity
- Trade Name
- Medical Imaging Solutions International FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- 1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
- Model / Reference
- 200102-A FDA UDI
- Description
- 1-65 mL & 1-115 ml Syringes 1-Large Spike, 1-Small Spike 1-96" Y Coiled Tubing with Dual Check Valves FDA UDI
Identifiers
- Catalog Number
- 100302 FDA UDI
- Primary DI / UDI-DI
- 06938327900984 FDA UDI
- 510(k) Number
- K151960 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Angiographic syringe 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
Medical Imaging Solutions International by Shenzhen Boon Medical Supply Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151960 also covers:
- LF — Shenzhen Boon Medical Supply Co., Ltd.
- LF — Shenzhen Boon Medical Supply Co., Ltd.
- LF — Shenzhen Boon Medical Supply Co., Ltd.
- LF — Shenzhen Boon Medical Supply Co., Ltd.
- Medical Imaging Solutions International — Shenzhen Boon Medical Supply Co., Ltd.
- Medical Imaging Solutions International — Shenzhen Boon Medical Supply Co., Ltd.
- Medical Imaging Solutions International — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- Steriatrics — Shenzhen Boon Medical Supply Co., Ltd.
- Steriatrics — Shenzhen Boon Medical Supply Co., Ltd.
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
- Shenzhen Boon Medical Supply Co., Ltd.
Sources (1)
- FDA UDI 152971fc-0a68-41db-895f-61b8bfa40cc5 36 fields · synced Jun 6, 2026