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BD Integra 305269

by Becton, Dickinson and Company

BD Integra 305269 is a Class II device made by Becton, Dickinson and Company, cleared under FDA 510(k) K011103 on 13 Jun 2001 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00382903052691), active as of 26 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 26 Oct 2026

Documents

510(k) K011103

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382903052691 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011103 Date13 Jun 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011103 decided 13 Jun 2001 Active
  • FDA GUDID UDI-DI 00382903052691 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K011103
  2. Listed FDA GUDID 00382903052691

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BD Integra
Generic name
Metered-delivery hypodermic syringe/needle
Model / Ref / Catalog
305269
Primary DI / UDI-DI
00382903052691
510(k) Number
FDA product code
MEG
GMDN term
Metered-delivery hypodermic syringe/needle
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3 Milliliter
Length — 0.625 Inch
Needle Gauge — 25 Gauge

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Properties

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