AccessGUDID - DEVICE: Neurotube (00844735006186)

GUDID

Device Identifier (DI) Information

Brand Name: Neurotube
Version or Model: GEM0240NT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 531101240011
Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC

Primary DI Number: 00844735006186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031284586 *Terms of Use

Device Description: The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed for primary or secondary peripheral nerve repair or reconstruction.

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":	No
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
JXI	CUFF, NERVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K983007	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 40 Millimeter
Lumen/Inner Diameter: 2.3 Millimeter

Device Record Status

Public Device Record Key: dcec7274-2d51-48f2-af50-a139b2b3ed6b
Public Version Date: August 20, 2024
Public Version Number: 3
DI Record Publish Date: April 23, 2019