FDA.reportPublic FDA data

Biodesign

Primary DI
00827002352476
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G35247
Catalog number
C-BRG-7X20-US
Device description
Biodesign Rectopexy 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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PAJMesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161221000
K992159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161221000Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated2016-05-26FTM
K992159000SURGISIS SLINGCook Biotech, Inc.1999-09-23PAG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002352473PackageGS11In Commercial Distribution
00827002352476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700235247310827002352473
00827002352476008270023524768270023524760827002352476

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
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
00827002447783BiodesignG44778C-IHM-6X13-P-B2015-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.PAJ2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.PAJ2026-03-24
00812337020671Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.PAJ2025-03-14
00812337020688Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.PAJ2025-03-14
00812337025300Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.PAJ2017-12-08
00812337025317Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.PAJ2017-12-08
00812337025324Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.PAJ2017-12-08
00812337025331Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.PAJ2017-12-08
00812337025348Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.PAJ2017-12-08
00812337025355Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.PAJ2017-12-08
10827002532035BiodesignCOOK BIOTECH INCORPORATEDPAJ2017-08-18
04041543311846Tutopatch™ bovine pericardium 6x8 cmTutogen Medical GmbHPAJ2015-12-14
04041543311853Tutopatch™ bovine pericardium 8x11 cmTutogen Medical GmbHPAJ2015-12-14
04041543311860Tutopatch™ bovine pericardium 8x14 cmTutogen Medical GmbHPAJ2015-12-14
04041543311877Tutopatch™ bovine pericardium 8x16 cmTutogen Medical GmbHPAJ2015-12-14
04041543311884Tutopatch™ bovine pericardium 8x18 cmTutogen Medical GmbHPAJ2015-12-14
04041543311891Tutopatch™ bovine pericardium10x12.5 cmTutogen Medical GmbHPAJ2015-12-14
04041543311907Tutopatch™ bovine pericardium 10x16 cmTutogen Medical GmbHPAJ2015-12-14
04041543311914Tutopatch™ bovine pericardium 12x12 cmTutogen Medical GmbHPAJ2015-12-14
04041543311921Tutopatch™ bovine pericardium 12x16 cmTutogen Medical GmbHPAJ2015-12-14
04041543311945Tutopatch™ bovine pericardium 14x20 cmTutogen Medical GmbHPAJ2015-12-14
04041543311952Tutomesh™ bovine pericardium10x16 cmTutogen Medical GmbHPAJ2015-12-14
04041543311969Tutomesh™ bovine pericardium 13x22 cmTutogen Medical GmbHPAJ2015-12-14
04041543311976Tutopatch™ bovine pericardium 6x18 cmTutogen Medical GmbHPAJ2015-12-14
14041543313472Tutopatch™ ECM 4 cm x 10 cmTutogen Medical GmbHPAJ2015-12-14
14041543313489Tutopatch™ ECM 7.5 cm x 10 cmTutogen Medical GmbHPAJ2015-12-14
14041543313496Tutopatch™ ECM 8 cm x 14 cmTutogen Medical GmbHPAJ2015-12-14
00085412531076VERITAS COLLAGEN MATRIXSYNOVIS LIFE TECHNOLOGIES, INC.PAJ2015-10-05
00085412531090VERITAS COLLAGEN MATRIXSYNOVIS LIFE TECHNOLOGIES, INC.PAJ2015-10-05
00085412531113VERITAS COLLAGEN MATRIXSYNOVIS LIFE TECHNOLOGIES, INC.PAJ2015-10-05