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polycarbonate syringes

by Dmc Medical Limited 9 variants

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K103736

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391530753999 UDI-DI Date1 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103736 Date10 Jun 2011DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
General-purpose syringe, reusable
Model / Ref / Catalog
FD-1094NS - 1ml PC Syringe Light Green Plunger 1ml Polycarbonate Syringe - Non-S
Primary DI / UDI-DI
05391530753999
510(k) Number
FDA product code
FMF
GMDN term
General-purpose syringe, reusable
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K103736)

Show all (12)

Other devices from Dmc Medical Limited

See all devices from Dmc Medical Limited →

Properties

  • Single use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No