FDA.reportPublic FDA data

Biodesign

Primary DI
10827002532035
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G53203
Catalog number
C-RRG-2X20
Device description
Biodesign Rectal Reinforcement 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
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
K022044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022044000SURGISIS STAPLE LINE REINFORCEMENTCook Biotech, Inc.2002-08-23OXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002532035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700253203510827002532035

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
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
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
00827002352476BiodesignCOOK BIOTECH INCORPORATEDPAJ2015-11-03
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