Home GUDID 00844868046158 OSSEOGUARD®
Primary DI 00844868046158
Brand OSSEOGUARD®
Company ZimVie US Corp LLC
Model TR150PN-N-1
Device description OSSEOGUARD® PTFE TR150 13 X 19 PERIO NARROW
Published 2023-05-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
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 00844868046158 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 00844868046158 00844868046158 844868046158 0844868046158
GMDN Terms# Term, Definition table Term Definition Pliable-polymer dental regeneration membrane, non-bioabsorbable A sterile non-bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 19 Millimeter Width 13 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 59 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 119287313 Device count 1 DM exempt true Lot or batch true Expiration date on label true 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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