allay™ Nerve Cap - Small Nerve Set

FDA UDI

Class II (US FDA UDI)

by Tulavi Therapeutics

Identity

Trade Name: allay™ Nerve Cap - Small Nerve Set FDA UDI
Generic Name: Nerve guide, synthetic polymer, bioabsorbable FDA UDI
Device Name: 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 - Small Nerve Set (1-4 mm) is provided in a sterile, non-pyrogenic for single use only. FDA UDI
Model / Reference: TL-5515-1 FDA UDI
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 - Small Nerve Set (1-4 mm) is provided in a sterile, non-pyrogenic for single use only. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860012518104 FDA UDI
510(k) Number: DEN230061 FDA UDI
FDA Product Code: SBG FDA UDI
GMDN Term: Nerve guide, synthetic polymer, bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5260 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Nerve guide, synthetic polymer, bioabsorbable

allay™ Nerve Cap - Small Nerve Set by Tulavi Therapeutics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

DEN230061 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Tulavi Therapeutics

Sources (1)

FDA UDI cf94d3f3-c875-4460-aa7c-df3703cdb4e7 35 fields · synced May 30, 2026