Home GUDID 10614950008701 REGENX PuraPLUG
Primary DI 10614950008701
Brand REGENX PuraPLUG
Company ACE SURGICAL SUPPLY CO., INC.
Model PGKTE1
Catalog number PGKTE1
Device description PuraKOTE 20x40x3mm, 10/BX Collagen Dental Dressing
Published 2016-12-15
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 LYC Bone grafting material, synthetic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LYC Bone Grafting Material, Synthetic Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10614950008701 Package GS1 10 In Commercial Distribution 00614950008704 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 10614950008701 10614950008701 00614950008704 00614950008704 614950008704 0614950008704
GMDN Terms# Term, Definition table Term Definition General oral wound dressing, animal-derived A sterile, collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution). It is available [non-prescription] over-the-counter (OTC) for clinical and home use. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Length 20 Millimeter Length 40 Millimeter Width 10 Millimeter Width 20 Millimeter
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 07640164360041 Gibson Healthcare Alloplast Degradable Solutions AG LYC 2024-03-05 07640164360065 Gibson Healthcare Alloplast Degradable Solutions AG LYC 2024-03-05 08720165038077 OsOpia RevisiOs B.V. LYC 2021-06-30 08809324764870 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764887 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764894 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764900 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764917 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764924 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764931 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764948 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764955 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764962 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764979 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764986 OSTEON GENOSS CO., Ltd. LYC 2018-07-10 08809324764993 OSTEON Sinus GENOSS CO., Ltd. LYC 2018-07-10 08809324765006 OSTEON Sinus GENOSS CO., Ltd. LYC 2018-07-10 08809324765013 OSTEON Lifting GENOSS CO., Ltd. LYC 2018-07-10 08809324765020 OSTEON Lifting GENOSS CO., Ltd. LYC 2018-07-10 08809324765082 OSTEON ll Sinus GENOSS CO., Ltd. LYC 2018-07-10 08809324765105 OSTEON ll Sinus GENOSS CO., Ltd. LYC 2018-07-10 08809324765136 OSTEON ll Lifting GENOSS CO., Ltd. LYC 2018-07-10 08809324765174 OSTEON ll Lifting GENOSS CO., Ltd. LYC 2018-07-10 08809324768014 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768021 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768038 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768045 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768052 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768069 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10 08809324768076 OsteonIII GENOSS CO., Ltd. LYC 2018-07-10
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