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Gentrix® EXT1640

by Acell, Inc.

Gentrix® EXT1640 is a Class II device made by Acell, Inc., listed in FDA GUDID since 25 Sep 2017 (UDI-DI 00386190001639), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number00386190001639 UDI-DI Date25 Sep 2017ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Gentrix®
Generic name
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Model / Ref / Catalog
EXT1640
Primary DI / UDI-DI
00386190001639
FDA product code
OXH, OXK, FTM
GMDN term
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Device class
Class II
Regulation number
878.3300
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Size
Width — 16 Centimeter
Length — 40 Centimeter

Other devices from Acell, Inc.

See all devices from Acell, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (8, all answered No)