AccessGUDID - DEVICE: Delivery Tip (00860012518128)

GUDID

Device Identifier (DI) Information

Brand Name: Delivery Tip
Version or Model: TL-7627
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TL-7627
Company Name: Tulavi Therapeutics, Inc.

Primary DI Number: 00860012518128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102780142 *Terms of Use

Device Description: The Delivery Tip system consists of a static mixer with an attached 22G blunt needle and with an additional unattached 18G blunt needle. The device is provided sterile and intended for single-use only by Rx. The Delivery Tip is indicated for use with the Dual Applicator in the allay™ Nerve Cap (TL-5515-1 and TL-5515-2) system only. The Delivery Tip is not designed, sold, or intended for use except as described by the Indication for Use.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
67326	Nerve cap delivery mixer/needle	A surgical device consisting of a fluid mixer and blunt needle intended to be attached to a dual-barrel syringe containing fluid preparation components of an implantable nerve cap agent, to mix the components and deliver the agent to the end of an amputated peripheral nerve for capping (shielding) during surgery. The nerve cap agent is intended to create physical barrier to reduce the risk of symptomatic neuroma; the syringe and nerve cap materials are not included. This is a single-use device.	Active	false

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: 50432dc8-e328-4adc-aee8-d369fb02a692
Public Version Date: September 30, 2024
Public Version Number: 1
DI Record Publish Date: September 20, 2024