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ViaMed 17318-R

by Rece International Corp.

ViaMed 17318-R is a Class II device made by Rece International Corp., cleared under FDA 510(k) K082042 on 3 Sep 2008 and listed in FDA GUDID since 20 Sep 2017 (UDI-DI 00811382018770), active as of 22 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 22 Oct 2026

Documents

510(k) K082042

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811382018770 UDI-DI Date20 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082042 Date3 Sep 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082042 decided 3 Sep 2008 Active
  • FDA GUDID UDI-DI 00811382018770 listed 20 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082042
  2. Listed FDA GUDID 00811382018770

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ViaMed
Generic name
Sharps container
Model / reference
17318-R
Primary DI / UDI-DI
00811382018770
510(k) Number
FDA product code
MMK
GMDN term
Sharps container
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MMK (Container, Sharps).

Other devices from Rece International Corp.

See all devices from Rece International Corp. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)