FDA.reportPublic FDA data

Biodesign

Primary DI
00827002362260
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G36226
Catalog number
C-AFP-0.6X9.5
Device description
Biodesign Anal Fistula Plug
Published
2024-03-28
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
FTMMesh, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050337000
K161221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050337000SIS FISTULA PLUGCook Biotech, Inc.2005-03-09FTM
K161221000Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated2016-05-26FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002362267PackageGS11In Commercial Distribution
00827002362260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700236226710827002362267
00827002362260008270023622608270023622600827002362260

GMDN Terms#

Term, Definition table
TermDefinition
Fistula-repair biomatrix implantA bioabsorbable, animal-derived substance intended to be implanted into a fistula tract (e.g., anal or rectal fistula) to close it by adding volume and promoting the ingrowth and neovascularization of host tissue. It consists primarily of an animal-derived matrix structure (e.g., made of collagen) that provides a scaffold for cell migration and growth, and which is gradually incorporated into and remodelled by host tissue. The material is typically preloaded in a disposable syringe.

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
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
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
00827002352476BiodesignG35247C-BRG-7X20-US2015-11-03
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

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