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Sinton Medical Products 100108-W

by Shenzhen Boon Medical Supply Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06938327909185 UDI-DI Date17 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sinton Medical Products
Generic Name
Angiography kit
Model / Ref / Catalog
100108-W, HS-NC200 Plus
Description
1-200ml Syringe 1-Fill Straw &1-Large Spike 1-72" Coiled Tubing
Primary DI / UDI-DI
06938327909185
510(k) Number
FDA Product Code
DXT
GMDN Term
Angiography kit
Device Class
Class II
Regulation Number
870.1650
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K241109)

Show all (12)

Other devices from Shenzhen Boon Medical Supply Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No