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Welmed 1300-10CNTL

by Welmed Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

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 Number00849296013413 UDI-DI Date15 Feb 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Welmed
Generic Name
General-purpose syringe, single-use
Model / Reference
1300-10CNTL
Primary DI / UDI-DI
00849296013413
510(k) Number
FDA Product Code
FMF
GMDN Term
General-purpose syringe, single-use
Device Class
Class II
Regulation Number
880.5860
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Related devices

Cleared under the same submission (K070936)

Show all (12)

Other devices from Welmed Inc.

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Properties

  • Single Use
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No