AccessGUDID - DEVICE: NeuraGen® 3D (10381780266716)

GUDID

Device Identifier (DI) Information

Brand Name: NeuraGen® 3D
Version or Model: PNGM220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PNGM220
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780266716
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: NeuraGen Advanced Nerve Guide Matrix 2mm x 2cm

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:	Yes
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 [?]
K163457	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
Special Storage Condition, Specify: Do Not Use if Package is Damaged.
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Centimeter
Outer Diameter: 2 Millimeter

Device Record Status

Public Device Record Key: 544ee7d0-f847-46ae-a357-232ff593f5d4
Public Version Date: March 05, 2024
Public Version Number: 3
DI Record Publish Date: December 15, 2022