Colorado Therapeutics Xenograft Implant XI0615-S+

GUDID 00868623000315

COLORADO THERAPEUTICS LLC

Abdominal hernia surgical mesh, collagen, antimicrobial
Primary Device ID00868623000315
NIH Device Record Key3fa3f75f-5879-4e97-948c-aeb375b7665e
Commercial Distribution StatusIn Commercial Distribution
Brand NameColorado Therapeutics Xenograft Implant
Version Model NumberXI-S+
Catalog NumberXI0615-S+
Company DUNS080356428
Company NameCOLORADO THERAPEUTICS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3034699459
Emailinfo@co-therapeutics.com

Device Dimensions

Height6 Centimeter
Height6 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100868623000315 [Primary]

FDA Product Code

OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00868623000315]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-04

On-Brand Devices [ Colorado Therapeutics Xenograft Implant]

00868623000360XI-S+
00868623000353XI-S+
00868623000346XI-S+
00868623000339XI-S+
00868623000322XI-S+
00868623000315XI-S+
00868623000308XI-S+
00860002305141XI-S+
00860002305134XI-S+
00860002305127XI-S+
00860002305110XI-S+
00860002305103XI-S+

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