AccessGUDID - DEVICE: NeuroShield (07640181710010)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroShield
Version or Model: NS4030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Monarch Bioimplants GmbH

Primary DI Number: 07640181710010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480144102 *Terms of Use

Device Description: NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve injuries by providing a protective barrierduring tissue healing.

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":	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?
43233	Nerve guide, animal-derived	An implantable tubular device made exclusively of animal-derived bioabsorbable material(s) [e.g., porcine-derived collagen matrix, chitosan] 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 intended 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXI	Cuff, Nerve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190246	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: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 115afdb5-d519-4b54-a3be-d83b2e907c54
Public Version Date: March 05, 2024
Public Version Number: 2
DI Record Publish Date: April 20, 2022