FDA.reportPublic FDA data

Biodesign

Primary DI
10827002602851
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
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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.
Special Storage Condition, Specify00Store the device in a clean, dry location at room temperature.

Sterilization Methods#

Method table
Method

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
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
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
00827002602854BiodesignCOOK 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