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Apligraf 1

by Organogenesis Inc.

Apligraf 1 is a Class III device made by Organogenesis Inc., listed in FDA GUDID since 24 Sep 2014 (UDI-DI 00618474000008), 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 Number00618474000008 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: 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  • Withdrawn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
Apligraf
Generic name
Skin regeneration template, human-/animal-derived
Model / reference
1
Primary DI / UDI-DI
00618474000008
FDA product code
PFC
GMDN term
Skin regeneration template, human-/animal-derived
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Skin regeneration template, human-/animal-derived

Similar devices

Also classified as Skin regeneration template, human-/animal-derived.

Other devices from Organogenesis Inc.

See all devices from Organogenesis Inc. →

Properties

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