FDA.reportPublic FDA data

Biodesign

Primary DI
00827002602854
Brand
Biodesign
Company
COOK BIOTECH INCORPORATED
Model
G60285
Catalog number
ENT-OTO-BFLY-0.4-0.6
Device description
Biodesign Otologic Butterfly Graft
Published
2024-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHJPOLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232646000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232646000Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech Incorporated2024-05-24KHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002602851PackageGS11In Commercial Distribution
00827002602854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700260285110827002602851
00827002602854008270026028548270026028540827002602854

GMDN Terms#

Term, Definition table
TermDefinition
ENT tissue biomatrix implantA bioabsorbable, animal-derived material intended to be surgically implanted to serve as a scaffold for soft tissue regeneration primarily in ear/nose/throat (ENT) procedures, typically in tympanum (eardrum) and/or nasal septum reconstruction; it may in addition be used as a membrane barrier to prevent undesired soft-tissue penetration into space intended for healing bone. It is available in a variety of sizes and shapes and consists primarily of an animal-derived matrix structure (e.g., equine collagen) which is gradually absorbed and replaced by host tissue.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850056665305ORCA FoamOrca Products, LLCKHJ2026-05-07
00810235030853Prolaryn PlusMERZ NORTH AMERICA, INC.KHJ2026-02-24
00850056665292ORCA Foam PowderOrca Products, LLCKHJ2025-09-30
00850056665223ORCA FoamOrca Products, LLCKHJ2025-04-07
00850056665247ORCA Foam PowderOrca Products, LLCKHJ2025-04-07
00850056665216ORCA FoamOrca Products, LLCKHJ2025-04-07
10850056665244ORCA Foam PowderOrca Products, LLCKHJ2025-04-07
00850056665193ORCA Foam Orca Products, LLCKHJ2025-02-25
00850056665100ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00850056665124ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
00850056665148ORCA Foam PowderOrca Products, LLCKHJ2024-12-05
10827002602851BiodesignCOOK BIOTECH INCORPORATEDKHJ2024-05-31
10860008294347ORCA FoamOrca Products, LLCKHJ2023-09-15
00850056665001ORCA FoamOrca Products, LLCKHJ2023-09-15
00850056665025ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294333ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294357ORCA FoamOrca Products, LLCKHJ2023-09-15
00860008294388ORCA FoamOrca Products, LLCKHJ2023-09-15
10860003109974ORCA FoamOrca Products, LLCKHJ2022-02-24
10860003109981ORCA FoamOrca Products, LLCKHJ2022-02-24
10860008294309ORCA FoamOrca Products, LLCKHJ2022-02-24
08033549791063Epifilm OtologicAnika Therapeutics, Inc.KHJ2022-02-04
04260293133076GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-28
04260293133106GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133144GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133175GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133199GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133083GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-07-27
04260293133069GELITA-SPON® STANDARDGELITA MEDICAL GmbHKHJ2021-03-21
00860003109915ORCA FoamOrca Products, LLCKHJ2020-12-15