Colorado Therapeutics Xenograft Implant XI1116B-S+

GUDID 00860002305110

COLORADO THERAPEUTICS LLC

Abdominal hernia surgical mesh, collagen, antimicrobial
Primary Device ID00860002305110
NIH Device Record Key3fd9598f-39b0-4d57-9afd-c6ecbe4d0f0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameColorado Therapeutics Xenograft Implant
Version Model NumberXI-S+
Catalog NumberXI1116B-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

Height16 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002305110 [Primary]

FDA Product Code

OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-20
Device Publish Date2019-09-12

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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