InnovaMatrix AC IMX-0404-01

GUDID 00850002643169

4cm x 4cm Placental ECM

Triad Life Sciences, Inc.

Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing Wound compression dressing

Primary Device ID	00850002643169
NIH Device Record Key	df96932b-94ef-4659-ac77-df813fbcadb0
Commercial Distribution Status	In Commercial Distribution
Brand Name	InnovaMatrix AC
Version Model Number	IMX-0404-01
Catalog Number	IMX-0404-01
Company DUNS	081037338
Company Name	Triad Life Sciences, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002643169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K193552

FDA Product Code

KGN	Dressing, Wound, Collagen

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-01-05
Device Publish Date	2021-12-28

On-Brand Devices [InnovaMatrix AC]

00850002643183	4cm x 6xm Placental ECM
00850002643176	5cm x 5cm Placental ECM
00850002643169	4cm x 4cm Placental ECM
00850002643152	2cm x 2cm Placental ECM
00850002643145	15mm Disc Placental ECM