Home GUDID 00324357900449 Zeni Medical
Primary DI 00324357900449
Brand Zeni Medical
Company Focus Health Group, Inc.
Model 90044
Published 2023-05-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name KGN Wound Dressing With Animal-Derived Material(S)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KGN Wound Dressing With Animal-Derived Material(S) Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30324357900440 Package GS1 10 In Commercial Distribution 50324357900444 Package GS1 20 In Commercial Distribution 00324357900449 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30324357900440 30324357900440 50324357900444 50324357900444 00324357900449 00324357900449 324357900449 0324357900449
GMDN Terms# Term, Definition table Term Definition Animal-derived wound matrix dressing A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.
Regulatory Flags# DUNS number 826939949 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860012016686 MaxioCel Chitosan Wound Dressing Advamedica Inc. KGN 2026-06-08 00850084084010 CURCO FR TECH, LLC KGN 2026-06-02 00850084084027 CURCO FR TECH, LLC KGN 2026-06-02 00850084084034 CURCO FR TECH, LLC KGN 2026-06-02 00850084084041 CURCO FR TECH, LLC KGN 2026-06-02 00850084084058 CURCO FR TECH, LLC KGN 2026-06-02 00850084084065 CURCO FR TECH, LLC KGN 2026-06-02 00850084084072 CURCO FR TECH, LLC KGN 2026-06-02 00850084084089 CURCO FR TECH, LLC KGN 2026-06-02 00714196003317 DermaCol 100 Gel 1oz Tube Sion Brands LLC KGN 2026-06-01 07610221017737 Derma-Gide® Geistlich Pharma AG KGN 2026-06-01 00813954028385 collatene COLLAGEN MATRIX, INC. KGN 2026-05-05 10840330705858 ProCure Twin Med, LLC KGN 2026-05-04 10840330705834 ProCure Twin Med, LLC KGN 2026-04-28 10840330705841 ProCure Twin Med, LLC KGN 2026-04-28 00812593023119 NeoForm AWC Biogennix, LLC KGN 2026-04-27 00812593023126 NeoForm AWC Biogennix, LLC KGN 2026-04-27 00812593023072 NeoSurg Surgical Collagen Biogennix, LLC KGN 2026-04-22 00812593023089 ossFX Surgical Collagen Biogennix, LLC KGN 2026-04-22 00812593023096 ossFX Surgical Collagen Biogennix, LLC KGN 2026-04-22 00812593023102 ColSyntek Biogennix, LLC KGN 2026-04-22 10885632434280 Halyard OWENS & MINOR DISTRIBUTION, INC. KGN 2026-04-16 10885632434297 Halyard OWENS & MINOR DISTRIBUTION, INC. KGN 2026-04-16 00324357900012 Zeni Medical Focus Health Group, Inc. KGN 2026-04-13 00324357900777 Zeni Medical Focus Health Group, Inc. KGN 2026-04-13 00812593023058 Agilon Surgical Collagen + Biogennix, LLC KGN 2026-04-02 00812593023065 Agilon Surgical Collagen + Biogennix, LLC KGN 2026-04-02 00812593023034 CuraSurg Surgical Collagen Biogennix, LLC KGN 2026-04-01 00812593023041 CuraSurg Surgical Collagen Biogennix, LLC KGN 2026-04-01 10885632434273 Halyard OWENS & MINOR DISTRIBUTION, INC. KGN 2026-03-31