allay™ Nerve Cap - Large Nerve Set

Primary DI
00860012518111
Brand
allay™ Nerve Cap - Large Nerve Set
Company
Tulavi Therapeutics, Inc.
Model
TL-5515-2
Device description
The allay™ Nerve Cap is a nerve cap made of an absorbable polyethylene glycol implant that provides a protective layer around the end of a transected peripheral nerve. The allay™ Nerve Cap forms in situ around a nerve end inside a temporary Cap Form. The hydrogel formed is a transparent, compliant nerve cover that conforms to and provides non-constricting encasement of the nerve end. The allay™ Nerve Cap provides a protective cover around the end of the nerve during the 3-month period associated with neuroma formation , after which the hydrogel is absorbed and cleared from the site within 8 months. The allay™ Nerve Cap - Large Nerve Set (5-7 mm) is provided in a sterile, non-pyrogenic for single use only.
Published
2024-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SBGIn Situ Polymerizing Peripheral Nerve Cap

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBGIn Situ Polymerizing Peripheral Nerve CapNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230061000allay Nerve CapTulavi Therapeutics2024-07-16SBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012518111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012518111008600125181118600125181110860012518111

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, synthetic-polymer, bioabsorbableAn implantable tubular device constructed of a bio-absorbable synthetic polymer(s) 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 designed 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
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
102780142
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012518128Delivery TipTL-7627TL-76272024-09-20
00860012518104allay™ Nerve Cap - Small Nerve SetTL-5515-12024-08-05
10860012518125Delivery TipTL-7627TL-76272024-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012518128Delivery TipTulavi Therapeutics, Inc.SBG2024-09-20
10860012518125Delivery TipTulavi Therapeutics, Inc.SBG2024-09-20
00860012518104allay™ Nerve Cap - Small Nerve SetTulavi Therapeutics, Inc.SBG2024-08-05