Home GUDID 00614950008780 REGENX PuraXEN
Primary DI 00614950008780
Brand REGENX PuraXEN
Company ACE SURGICAL SUPPLY CO., INC.
Model PGAB25L
Catalog number PGAB25L
Device description PuraXEN Cancellous 2.5cc 1-2mm Particulate
Published 2017-01-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NPM BONE GRAFTING MATERIAL, ANIMAL SOURCE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NPM Bone Grafting Material, Animal Source Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00614950008780 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 00614950008780 00614950008780 614950008780 0614950008780
GMDN Terms# Term, Definition table Term Definition Dental bone matrix implant, animal-derived A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 042763706 Device count 1 DM exempt true 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 00813954028484 XENOFY-P COLLAGEN MATRIX, INC. NPM 2026-03-12 00813954028491 XENOFY-P COLLAGEN MATRIX, INC. NPM 2026-03-12 00813954028507 XENOFY-P COLLAGEN MATRIX, INC. NPM 2026-03-12 00813954028514 XENOFY-P COLLAGEN MATRIX, INC. NPM 2026-03-12 00813954028521 XENOFY-P COLLAGEN MATRIX, INC. NPM 2026-03-12 00813954028538 XENOFY-P COLLAGEN MATRIX, INC. NPM 2026-03-12 08809490621878 OCTABONE CHIYEWON.LTD NPM 2026-02-02 08809490621885 OCTABONE CHIYEWON.LTD NPM 2026-02-02 08809490621892 OCTABONE CHIYEWON.LTD NPM 2026-02-02 08809490621908 OCTABONE CHIYEWON.LTD NPM 2026-02-02 08809490621977 OCTABONE CHIYEWON.LTD NPM 2026-02-02 08809490621984 OCTABONE CHIYEWON.LTD NPM 2026-02-02 08809490621946 TI-OSS CHIYEWON.LTD NPM 2026-01-28 08809490621953 TI-OSS CHIYEWON.LTD NPM 2026-01-28 00813954027739 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027746 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027753 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027760 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027777 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027784 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027791 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027807 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027814 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027821 NuOss COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027913 MinerOss X Collagen COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027920 MinerOss X Collagen COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027937 MinerOss X Collagen COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027944 NuOss Collagen COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027951 NuOss Collagen COLLAGEN MATRIX, INC. NPM 2026-01-07 00813954027968 NuOss Collagen COLLAGEN MATRIX, INC. NPM 2026-01-07
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