FDA.reportPublic FDA data

Biodesign

Primary DI
00827002314559
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G31455
Catalog number
C-PHR-7X10-U
Device description
Biodesign Hiatal Hernia Graft
Published
2015-11-03
Public version status
Update
Distribution status
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
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
00827002314559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002314559008270023145598270023145590827002314559

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
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
10827002565804BiodesignCOOK 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