FDA.reportPublic FDA data

BIODESIGN

Primary DI
00810179630546
Brand
BIODESIGN
Company
COOK BIOTECH INCORPORATED
Model
G44452
Catalog number
ENT-OTO-5X5
Device description
Biodesign Otologic Repair Graft
Published
2026-07-31
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
K150594000
K161000000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150594000Biodesign Otologic Repair GraftCook Biotech Incorprated2015-09-16KHJ
K161000000Biodesign Otologic Repair GraftCook Biotech Incorporated2016-05-11KHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002444522PreviousGS10
00810179630546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002444522008270024445228270024445220827002444522
00810179630546008101796305468101796305460810179630546

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobialA 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]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

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(765)497-3355CBIRegulatory@evergenbio.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
00810179630065AxoGuardG52789AG02202026-07-31
00810179630089AxoGuardG52790AG03202026-07-31
00810179630102AxoGuardG52791AG03402026-07-31
00810179630126AxoGuardG52792AG05202026-07-31
00810179630140AxoGuardG52804AG05402026-07-31
00810179630164AxoGuardG52803AG07202026-07-31
00810179630188AxoGuardG52802AG07402026-07-31
00810179630201AxoGuardG52801AG10202026-07-31
00810179630225AxoGuardG52800AG10402026-07-31
00810179630263AxoGuardG35128AGX1152026-07-31
00810179630287AxoGuardG52798AGX2102026-07-31
00810179630300AxoGuardG35130AGX2152026-07-31
00810179630324AxoGuardG52797AGX3102026-07-31
00810179630348AxoGuardG35131AGX3152026-07-31
00810179630362AxoGuardG52796AGX4102026-07-31
00810179630386AxoGuardG35132AGX4152026-07-31
00810179630409AxoGuardG52795AGX5102026-07-31
00810179630423AxoGuardG35133AGX5152026-07-31
00810179630447AxoGuardG52794AGX6102026-07-31
00810179630461AxoGuardG35134AGX6152026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179630683BiodesignCOOK BIOTECH INCORPORATEDKHJ2026-07-31
00810179630706BiodesignCOOK BIOTECH INCORPORATEDKHJ2026-07-31
00810179630713BIODESIGNCOOK BIOTECH INCORPORATEDKHJ2026-07-31
00810179630744BiodesignCOOK BIOTECH INCORPORATEDKHJ2026-07-31
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
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