AxoGuard

Primary DI
00810179630478
Brand
AxoGuard
Company
COOK BIOTECH INCORPORATED
Model
G52793
Catalog number
AGX710
Device description
AxoGuard Nerve Connector
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
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
00827002527935PreviousGS10
00810179630478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002527935008270025279358270025279350827002527935
00810179630478008101796304788101796304780810179630478

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, animal-derivedAn implantable tubular device made exclusively of animal-derived bioabsorbable material(s) [e.g., porcine-derived collagen matrix, chitosan] intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is intended to be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.

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
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
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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