AccessGUDID - DEVICE: NeuraGen® (10381780071822)

GUDID

Device Identifier (DI) Information

Brand Name: NeuraGen®
Version or Model: PNG130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PNG-130
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780071822
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: NeuraGen® Nerve Guide 1.5mm (ID) X 3cm (Length)

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?
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 [?]
K011168	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: Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.5mm (ID) x3cm (Length)

Device Record Status

Public Device Record Key: 205a794e-ab2e-4e5d-a370-871cc0678a48
Public Version Date: March 05, 2024
Public Version Number: 8
DI Record Publish Date: September 22, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	M269PNG1301

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)654-2873
Email: custsvcnj@integralife.com

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