Skip to content

ASTEC ICSI Injection Pipette

by Astec Bio USA Inc 27 variants

ASTEC ICSI Injection Pipette (AI5025-FR) is a Class II device made by Astec Bio USA Inc, listed in FDA GUDID since 12 Nov 2020 (UDI-DI B951AI5025FR1), 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 NumberB951AI5025FR1 UDI-DI Date12 Nov 2020ListedStatusListed 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  • Withdrawn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
Astec
Generic name
Assisted reproduction microtool
Model / Ref / Catalog
ICSI Injection Pipette, AI5025-FR
Primary DI / UDI-DI
B951AI5025FR1
FDA product code
PUC
GMDN term
Assisted reproduction microtool
Device class
Class II
Regulation number
884.6130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Assisted reproduction microtool

Other devices from Astec Bio USA Inc

See all devices from Astec Bio USA Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)