Identity
- Trade Name
- Genus FDA UDI
- Generic Name
- Angiographic catheter, single-use FDA UDI
- Device Name
- 2-200ml Syringes 2-Fill Straws 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
- Model / Reference
- 100114-A FDA UDI
- Description
- 2-200ml Syringes 2-Fill Straws 1-60" Y Coiled Tubing with Dual Check Valves FDA UDI
Identifiers
- Catalog Number
- 128-200107D FDA UDI
- Primary DI / UDI-DI
- 06938327904623 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Angiographic catheter, single-use 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 catheter, single-use
Genus by Shenzhen Boon Medical Supply Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 c6a012a2-2e65-49fe-ae43-b6b646ce9cd1 36 fields · synced May 30, 2026