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Terumo Ss-30S

by Terumo (Philippines) Corporation

Terumo Ss-30S is a Class II device made by Terumo (Philippines) Corporation, cleared under FDA 510(k) K063613 on 26 Dec 2006 and listed in FDA GUDID since 2 Sep 2016 (UDI-DI 34806017511419), active as of 23 Oct 2026.

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) K063613

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number34806017511419 UDI-DI Date2 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK063613 Date26 Dec 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063613 decided 26 Dec 2006 Active
  • FDA GUDID UDI-DI 34806017511419 listed 2 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063613
  2. Listed FDA GUDID 34806017511419

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Terumo
Generic name
Metered-delivery hypodermic syringe
Model / reference
SS-30S
Primary DI / UDI-DI
34806017511419
510(k) Number
FDA product code
FMF
GMDN term
Metered-delivery hypodermic syringe
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 30 Milliliter

Other devices from Terumo (Philippines) Corporation

See all devices from Terumo (Philippines) Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)