FDA.reportPublic FDA data

AxoGuard

Primary DI
00827002351288
Brand
AxoGuard
Company
COOK BIOTECH INCORPORATED
Model
G35128
Catalog number
AGX115
Device description
AxoGuard Nerve Connector
Published
2015-11-03
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
JXICUFF, NERVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXICuff, NerveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031069000
K162741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031069000SURGISIS NERVE CUFFCook Biotech, Inc.2003-05-15JXI
K162741000AxoGuard Nerve ConnectorCook Biotech Incorporated2016-10-31JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002351285PackageGS11In Commercial Distribution
00827002351288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700235128510827002351285
00827002351288008270023512888270023512880827002351288

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 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
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
00810179630065AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630089AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630102AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630126AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630140AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630164AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630188AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630201AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630225AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630263AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630287AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630300AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630324AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630348AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630362AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630386AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630409AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630423AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630447AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630461AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630478AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630492AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00813954029214CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029221CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029238CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029245CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029252CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-30
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