FDA.reportPublic FDA data

Biodesign

Primary DI
00827002542525
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G54252
Catalog number
C-SLRA-OPEN-GIA80
Device description
Biodesign Staple Line Reinforcement
Published
2015-11-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXEMesh, surgical, collagen, staple line reinforcement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXEMesh, Surgical, Collagen, Staple Line ReinforcementGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070405000
K170945000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070405000MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENTCook Biotech, Inc.2007-10-17FTM
K170945000Biodesign Staple Line ReinforcementCook Biotech Incorporated2017-04-28OXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002542525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002542525008270025425258270025425250827002542525

GMDN Terms#

Term, Definition table
TermDefinition
Staple line-reinforcement stripA sterile bioabsorbable device made of material derived from animal tissue intended to buttress staple lines and control leaks of blood, fluids, and air from around staple lines typically during cardiothoracic and abdominal surgeries. It is typically available as strips of material provided with an adhesive hydrogel to facilitate rehydration of the strips and their temporary adherence to the stapler loader unit before application of the staples with the strips to the tissue. This is a single-use device.

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.OXE2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.OXE2026-03-24
00812337020671Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2025-03-14
00812337020688Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2025-03-14
00085412658681Peri-Strips Dry with VeritasSYNOVIS LIFE TECHNOLOGIES, INC.OXE2024-11-21
00085412658834Peri-Strips Dry with VeritasSYNOVIS LIFE TECHNOLOGIES, INC.OXE2024-11-21
50085412658686Peri-Strips Dry with VeritasSYNOVIS LIFE TECHNOLOGIES, INC.OXE2024-11-21
00085412658780PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2021-12-01
00085412658841PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2021-12-01
50085412658785PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2021-12-01
00085412658797PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-04-23
00085412658858PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-04-23
00085412658803PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-02-10
00085412658865PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-02-10
50085412658808PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-02-10
50085412658860PERI-STRIPS DRY WITH VERITASWITH SECURE GRIPSYNOVIS LIFE TECHNOLOGIES, INC.OXE2020-02-10
00812337023719TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023726TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023733TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023740TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023757TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023764TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337023771TrelliFormDSM BIOMEDICAL, INC.OXE2019-10-07
00812337025300Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025317Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025324Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025331Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025348Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00812337025355Meso BioMatrix® Acellular Peritoneum Matrix DSM BIOMEDICAL, INC.OXE2017-12-08
00827002232013BiodesignCOOK BIOTECH INCORPORATEDOXE2015-11-03