FDA.reportPublic FDA data

Biodesign

Primary DI
00827002482166
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G48216
Catalog number
C-SLH-8H-20X30
Device description
Biodesign Hernia Graft
Published
2015-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
10827002482163PackageGS11In Commercial Distribution
00827002482166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700248216310827002482163
00827002482166008270024821668270024821660827002482166

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobialA 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]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.

Contacts#

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

Regulatory Flags#

DUNS number
945385862
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10827002239460BiodesignCOOK BIOTECH INCORPORATEDOXK2017-08-18
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