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Peak Medical Ar-13

by PEAK MEDICAL Distribution Inc

Peak Medical Ar-13 is a Class I device made by PEAK MEDICAL Distribution Inc, listed in FDA GUDID since 11 Mar 2026 (UDI-DI G453AR130), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberG453AR130 UDI-DI Date11 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Peak Medical
Generic name
Exploratory blunt needle, single-use
Model / reference
AR-13
Description
Aortic Root 13 gauge Needle, Luer lock, 45 degree sharp tip, working length 0.5" (1.27CM), Overall length 1-1/8" (2.87CM)
Primary DI / UDI-DI
G453AR130
FDA product code
GEA
GMDN term
Exploratory blunt needle, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from PEAK MEDICAL Distribution Inc

See all devices from PEAK MEDICAL Distribution Inc →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)