Axoguard HA+ Nerve Protector

Primary DI
10850828007142
Brand
Axoguard HA+ Nerve Protector
Company
AXOGEN CORPORATION
Model
AGHA48
Device description
Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for non-transected peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
Published
2023-04-24
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
K223640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223640000Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)Axogen Corporation2023-04-07JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850828007142PackageGS11In Commercial Distribution
00850828007145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085082800714210850828007142
00850828007145008508280071458508280071450850828007145

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, bioabsorbable, animal-derivedAn implantable tubular device 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 made of an animal-derived material (e.g., porcine-derived collagen matrix, chitosan) that can 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, Specify00Axoguard HA+ Nerve Protector should be stored in a clean, dry location at room temperature. Do not store in direct sunlight due to risk of heat.
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8882964361customercare@axogeninc.com

Regulatory Flags#

DUNS number
113424464
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
10850828007012AcroGrip™ DeviceEN-2472017-05-15
10850828007029AcroPinch™ DeviceEN-2482017-05-15
10850828007036AxoTouch™ Two-Point Discriminator2PDGA12017-05-15
00850828007107Axoguard HA+ Nerve ProtectorAGHA122023-04-24
00850828007114Axoguard HA+ Nerve ProtectorAGHA222023-04-24
00850828007121Axoguard HA+ Nerve ProtectorAGHA242023-04-24
00850828007138Axoguard HA+ Nerve ProtectorAGHA362023-04-24
00850828007145Axoguard HA+ Nerve ProtectorAGHA482023-04-24
00850828007046AxoGuard Nerve CapAGT2152017-10-24
00850828007053AxoGuard NerveCapAGT3152017-10-24
00850828007060AxoGuard Nerve CapAGT4152017-10-24
00850828007077AxoGuard Nerve CapAGT5202017-10-24
00850828007084AxoGuard Nerve CapAGT6202017-10-24
00850828007091AxoGuard Nerve CapAGT7202017-10-24
10850828007104Axoguard HA+ Nerve ProtectorAGHA122023-04-24
10850828007111Axoguard HA+ Nerve ProtectorAGHA222023-04-24
10850828007128Axoguard HA+ Nerve ProtectorAGHA242023-04-24
10850828007135Axoguard HA+ Nerve ProtectorAGHA362023-04-24

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