Home GUDID 17290013396058 InSpace™
Primary DI 17290013396058
Brand InSpace™
Company ORTHO-SPACE LTD
Model 0131
Catalog number 0131
Device description InSpace™ system, MediumThe InSpace™ Subacromial Tissue Spacer System is a Shoulder spacer for massive irreparable rotator cuff tears, resorbable, inflatable, non-fixed.The InSpace™ Subacromial Tissue Spacer System implant is designed to act as a spacer, creating a physical barrier between tissues in the subacromial space. It is supplied sterile (EtO) and intended for single use.
Published 2021-08-01
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name QPQ Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QPQ Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17290013396058 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 17290013396058 17290013396058
GMDN Terms# Term, Definition table Term Definition Tendon spacer An implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 29 Degrees Celsius
Regulatory Flags# DUNS number 533152083 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 17290013396041 InSpace™ 0130 0130 2021-08-01 17290013396065 InSpace™ 0132 0132 2021-08-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 17290013396041 InSpace™ ORTHO-SPACE LTD QPQ 2021-08-01 17290013396065 InSpace™ ORTHO-SPACE LTD QPQ 2021-08-01