Colorado Therapeutics Xenograft Implant XI0508-S+

GUDID 00868623000322

COLORADO THERAPEUTICS LLC

Abdominal hernia surgical mesh, collagen, antimicrobial
Primary Device ID00868623000322
NIH Device Record Keyd1c623e3-ec37-40e0-8141-108702d99fe2
Commercial Distribution StatusIn Commercial Distribution
Brand NameColorado Therapeutics Xenograft Implant
Version Model NumberXI-S+
Catalog NumberXI0508-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

Length8 Centimeter
Length8 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100868623000322 [Primary]

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00868623000322]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-13
Device Publish Date2019-03-05

On-Brand Devices [ Colorado Therapeutics Xenograft Implant]

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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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