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
10827002311418BiodesignG31141C-IHM-10X152015-11-03
10827002314518BiodesignG31451C-IHM-6X13-P2015-11-03
10827002314525BiodesignG31452C-IHM-8X15-P2015-11-03
00827002231191OASISG231198213-0000-132019-03-11
00827002352421OASISG352428213-0000-162019-03-11
00827002352438OASISG352438213-0000-172019-03-12
00827002352445OASISG352448213-0000-182019-03-11
00827002352452OASISG352458213-0000-192019-03-11
00827002466227OASISG466228213-1000-332019-03-11
00827002466234OASISG466238213-2000-332019-04-17
00827002466265OASISG466268213-1000-372019-03-11
00827002466272OASISG466278213-2000-372019-04-17
00827002564633OASISG564638213-0000-092019-03-11
00827002564657OASISG564658213-0000-112019-03-11
00827002576018OASISG576018213-3000-092019-03-11
00827002576025OASISG576028213-3000-112019-03-11
00827002576032OASISG576038213-3000-132019-03-11
00827002576049OASISG576048213-3000-162019-03-11
00827002576056OASISG576058213-3000-172019-03-11
00827002576063OASISG576068213-3000-182019-03-11

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