FDA.reportPublic FDA data

Biodesign

Primary DI
10827002565804
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G56580
Catalog number
C-PRG-20D
Device description
Biodesign Parastomal Reinforcement Graft
Published
2015-11-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWVMesh, surgical, collagen, diaphragmatic hernia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWVMesh, Surgical, Collagen, Diaphragmatic HerniaGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133011000DIAPHRAGMATIC HERNIA GRAFTCook Biotech, Inc.2014-06-20OWV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002565804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700256580410827002565804

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 dark, dry, cool place.
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
Manufacturing date on label
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
00085412818313Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00085412818375Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00085412818405Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00085412818429Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00085412818443Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00085412818597Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00085412818610Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00085412818658Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00085412818672Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00085412818696Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2023-05-15
00386190001592Gentrix®ACELL, INC.OWV2019-02-15
00386190001844Gentrix®ACELL, INC.OWV2019-02-15
00386190001851Gentrix®ACELL, INC.OWV2019-02-15
00386190001868Gentrix®ACELL, INC.OWV2019-02-15
00386190001875Gentrix®ACELL, INC.OWV2019-02-15
00386190001882Gentrix®ACELL, INC.OWV2019-02-15
00386190001899Gentrix®ACELL, INC.OWV2019-02-15
00386190001905Gentrix®ACELL, INC.OWV2019-02-15
00386190001912Gentrix®ACELL, INC.OWV2019-02-15
00386190001929Gentrix®ACELL, INC.OWV2019-02-15
00386190001936Gentrix®ACELL, INC.OWV2019-02-15
00386190001943Gentrix®ACELL, INC.OWV2019-02-15
00386190001950Gentrix®ACELL, INC.OWV2019-02-15
00386190001967Gentrix®ACELL, INC.OWV2019-02-15
00827002314559BiodesignCOOK BIOTECH INCORPORATEDOWV2015-11-03
00827002515789BiodesignCOOK BIOTECH INCORPORATEDOWV2015-11-03
00085412530529Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2015-10-08
00085412530567Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2015-10-08
00085412530581Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2015-10-08
00085412530604Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.OWV2015-10-08