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
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
00827002482166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

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

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

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.
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
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