Home GUDID 00868623000322 Colorado Therapeutics Xenograft Implant
Primary DI 00868623000322
Brand Colorado Therapeutics Xenograft Implant
Company COLORADO THERAPEUTICS LLC
Model XI-S+
Catalog number XI0508-S+
Published 2019-03-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FTM Mesh, Surgical OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FTM Mesh, Surgical General, Plastic Surgery 2 OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00868623000322 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 00868623000322 00868623000322 868623000322 0868623000322
GMDN Terms# Term, Definition table Term Definition Abdominal hernia surgical mesh, collagen, antimicrobial A sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it includes a pharmaceutical antibacterial agent. It may also be used as a short-term scaffold for tissue regeneration; it is not designed specifically for diaphragmatic hernia repair and has no extra-abdominal applications. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Height 5 Centimeter Length 8 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 40 Degrees Celsius Storage Environment Temperature 35.6 Degrees Fahrenheit 104 Degrees Fahrenheit
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 080356428 Device count 1 Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00868623000353 Colorado Therapeutics Xenograft Implant XI-S+ XI0203-S+ 2019-03-05 00868623000360 Colorado Therapeutics Xenograft Implant XI-S+ XI0404-S+ 2019-03-05 00860002305103 Colorado Therapeutics Xenograft Implant XI-S+ XI1116A-S+ 2019-09-12 00860002305110 Colorado Therapeutics Xenograft Implant XI-S+ XI1116B-S+ 2019-09-12 00860002305127 Colorado Therapeutics Xenograft Implant XI-S+ XI1014A-S+ 2019-09-12 00860002305134 Colorado Therapeutics Xenograft Implant XI-S+ XI1014B-S+ 2019-09-12 00860002305141 Colorado Therapeutics Xenograft Implant XI-S+ XI0909C-S+ 2019-09-12 00868623000339 Colorado Therapeutics Xenograft Implant XI-S+ XI0808-S+ 2019-03-05 00868623000346 Colorado Therapeutics Xenograft Implant XI-S+ XI0710-S+ 2019-03-05 00868623000308 Colorado Therapeutics Xenograft Implant XI-S+ XI0606-S+ 2017-04-04 00868623000315 Colorado Therapeutics Xenograft Implant XI-S+ XI0615-S+ 2017-04-04
Other Devices Sharing Product Codes# 
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