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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 syringe FDA UDI
Device Name
1-65 mL & 1-115 ml Syringes 1-Large Spike & 1-Small Spike 1-96" T Coiled Tubing with Check Valve FDA UDI
Model / Reference
200102- B FDA UDI
Description
1-65 mL & 1-115 ml Syringes 1-Large Spike & 1-Small Spike 1-96" T Coiled Tubing with Check Valve FDA UDI

Identifiers

Catalog Number
HS-MMD115T FDA UDI
Primary DI / UDI-DI
06938327900564 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
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

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Manufacturer

Manufacturer
Shenzhen Boon Medical Supply Co., Ltd.

Sources (1)

  • FDA UDI 5809e56e-7ca1-47f7-938f-92da43d69af4 37 fields · synced May 30, 2026