AccessGUDID - DEVICE: allay™ Nerve Cap - Small Nerve Set (00860012518104)

GUDID

Device Identifier (DI) Information

Brand Name: allay™ Nerve Cap - Small Nerve Set
Version or Model: TL-5515-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tulavi Therapeutics, Inc.

Primary DI Number: 00860012518104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102780142 *Terms of Use

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 - Small Nerve Set (1-4 mm) is provided in a sterile, non-pyrogenic for single use only.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44814	Nerve guide, synthetic polymer, bioabsorbable	An implantable device intended to be used 1) to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve ends, 2) to encase a nerve for protection to aid in repair [e.g., to prevent ingrowth of scar tissue], or 3) for capping the end of an amputated nerve to prevent the formation of a neuroma. It is made of bioabsorbable synthetic polymer(s) in the form of a solid tube or a gel which polymerises in situ, and is designed to be chemically degraded and absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, nerve wrap, or nerve cap.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
SBG	In Situ Polymerizing Peripheral Nerve Cap

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230061	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf94d3f3-c875-4460-aa7c-df3703cdb4e7
Public Version Date: August 20, 2024
Public Version Number: 2
DI Record Publish Date: August 05, 2024