Axoguard HA+ Nerve Protector

Primary DI
00850828007138
Brand
Axoguard HA+ Nerve Protector
Company
AXOGEN CORPORATION
Model
AGHA36
Device description
Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.K223640: 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. K231708: Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also provides tension relief when used as a coaptation aid. 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 has sufficient mechanical strength to hold sutures.
Published
2023-04-24
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850828007135PackageGS11In Commercial Distribution
00850828007138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085082800713510850828007135
00850828007138008508280071388508280071380850828007138

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, 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

Contacts#

Phone, Email table
PhoneEmail
8882964361customercare@axogeninc.com

Regulatory Flags#

DUNS number
113424464
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
10850828007142Axoguard HA+ Nerve ProtectorAGHA482023-04-24

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