AccessGUDID - DEVICE: Integra® (10381780024361)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: NL8501902
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NL8501902
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780024361
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: Integra® NeuroSciences Connector Pudenz Right-Angle Connector

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
47515	Cerebrospinal fluid shunt connector	An implantable device intended to create a fluid path connection between components of a cerebrospinal fluid (CSF) shunt assembly (e.g., lumbar and/or peritoneal catheters of a ventriculoperitoneal or lumboperitoneal shunt), designed to remove excess cerebrospinal fluid from around the central nervous system especially in the treatment of hydrocephalus. It is typically made of plastic or metal and is available in various designs (L-, Y- or cross-shaped, straight).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: SpeciaAvoid contaminants such as lint, fingerprints, or talc.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.1mm ID x 1.9mm OD (all dimensions nominal)

Device Record Status

Public Device Record Key: cfe066c0-9832-4640-9b40-b367ff9849e5
Public Version Date: May 16, 2023
Public Version Number: 6
DI Record Publish Date: December 15, 2016

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	M269NL85019021

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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