FDA.reportPublic FDA data

Biodesign

Primary DI
10827002239460
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G23946
Catalog number
C-BIG-10X40
Device description
Biodesign Incision Graft
Published
2017-08-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXKMesh, surgical, collagen, large abdominal wall defects

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXKMesh, Surgical, Collagen, Large Abdominal Wall DefectsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133306000SIS HERNIA GRAFTCook Biotech, Inc.2014-07-23FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002239460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700223946010827002239460

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbableA bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It is constructed of cross-linked collagen (e.g., with glutaraldehyde) and may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in clean, dry location at room temperature
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
945385862
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002512986DynaMatrixG5129810.401.20302015-11-03
00827002125797BiodesignG12579C-SLH-4S-7X202015-11-03
00827002125803BiodesignG12580C-SLH-4S-7X102015-11-03
00827002128477BiodesignG12847SLH-1S-7X102015-11-03
00827002131811BiodesignG13181C-SLH-4S-4X72015-11-03
00827002132214BiodesignG13221C-SLH-1S-2X32015-11-03
00827002135444BiodesignG13544C-SLH-4S-1X102015-11-03
00827002237643BiodesignG23764C-SLH-8H-10X102015-11-03
00827002313200BiodesignG31320C-SLH-4S-2X32015-11-03
00827002314559BiodesignG31455C-PHR-7X10-U2015-11-03
00827002352476BiodesignG35247C-BRG-7X20-US2015-11-03
00827002359475BiodesignG35947ENT-TRG-1X22015-11-03
00827002359482BiodesignG35948ENT-TRG-2X32015-11-03
00827002359499BiodesignG35949ENT-TRG-4X72015-11-03
00827002359505BiodesignG35950ENT-TRG-7X102015-11-03
00827002360327BiodesignG36032C-SLH-8H-13X152015-11-03
00827002360334BiodesignG36033C-SLH-8H-20X202015-11-03
00827002444515BIODESIGNG44451ENT-OTO-2.5X2.52015-11-03
00827002444522BIODESIGNG44452ENT-OTO-5X52015-11-03
00827002447776BiodesignG44777C-IHM-10X15-B2015-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00386190002681Gentrix®ACELL, INC.OXK2020-08-21
00386190002698Gentrix®ACELL, INC.OXK2020-08-21
00860002305103 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-09-12
00860002305110 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-09-12
00860002305127 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-09-12
00860002305134 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-09-12
00860002305141 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-09-12
00868623000322 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-03-05
00868623000339 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-03-05
00868623000346 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-03-05
00868623000353 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-03-05
00868623000360 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2019-03-05
00386190001776Gentrix®ACELL, INC.OXK2018-01-04
00386190001783Gentrix®ACELL, INC.OXK2018-01-04
00386190001790Gentrix®ACELL, INC.OXK2018-01-04
00386190001813Gentrix®ACELL, INC.OXK2018-01-04
00386190001608Gentrix®ACELL, INC.OXK2017-09-25
00386190001615Gentrix®ACELL, INC.OXK2017-09-25
00386190001622Gentrix®ACELL, INC.OXK2017-09-25
00386190001639Gentrix®ACELL, INC.OXK2017-09-25
00386190001523Gentrix®ACELL, INC.OXK2017-06-30
00386190001530GentrixACELL, INC.OXK2017-06-30
00386190001547Gentrix®ACELL, INC.OXK2017-06-30
00386190001554Gentrix®ACELL, INC.OXK2017-06-30
00386190001561Gentrix®ACELL, INC.OXK2017-06-30
00386190001578Gentrix®ACELL, INC.OXK2017-06-30
00386190001585Gentrix®ACELL, INC.OXK2017-06-30
00868623000308 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2017-04-04
00868623000315 Colorado Therapeutics Xenograft ImplantCOLORADO THERAPEUTICS LLCOXK2017-04-04
00827002237643BiodesignCOOK BIOTECH INCORPORATEDOXK2015-11-03