← Back to catalogue

Sinton Medical Products

FDA UDI

Class II (US FDA UDI)

by Shenzhen Boon Medical Supply Co., Ltd.

Identity

Trade Name
Sinton Medical Products FDA UDI
Generic Name
Angiographic catheter, single-use FDA UDI
Device Name
200mm Y Tubing with Dual Check Valves FDA UDI
Model / Reference
400102-5 FDA UDI
Description
200mm Y Tubing with Dual Check Valves FDA UDI

Identifiers

Catalog Number
HT-LY202 FDA UDI
Primary DI / UDI-DI
06938327900762 FDA UDI
510(k) Number
K151960 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
Not 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

Sinton Medical Products by Shenzhen Boon Medical Supply Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151960 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Boon Medical Supply Co., Ltd.

Sources (1)

  • FDA UDI 7225c2b3-9830-447d-9a4b-0bfae414924d 37 fields · synced May 30, 2026