AxoGuard NerveCap

Primary DI
00850828007053
Brand
AxoGuard NerveCap
Company
AXOGEN CORPORATION
Model
AGT315
Device description
The AxoGuard® Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device isolates the nerve stump from the surrounding soft tissue bed by pulling the nerve into the tube and suturing the nerve within the cap. The end of the cap has a suturable tab to allow the surgeon to suture the device to surrounding tissue. AxoGuard® Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, AxoGuard® Nerve Cap is easy to handle, soft, pliable, nonfriable and porous. AxoGuard® Nerve Cap is flexible and pliable to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized non-absorbable suture. AxoGuard® Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.
Published
2017-10-24
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
10850828007050PackageGS11In Commercial Distribution
00850828007053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085082800705010850828007050
00850828007053008508280070538508280070530850828007053

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 a collagen matrix material (e.g., porcine-derived) 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
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Store in clean, dry location at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888.296.4361CustomerCare@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
00850828007138Axoguard HA+ Nerve ProtectorAGHA362023-04-24
00850828007145Axoguard HA+ Nerve ProtectorAGHA482023-04-24
00850828007046AxoGuard Nerve CapAGT2152017-10-24
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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