AccessGUDID - DEVICE: Integra® (10381780072287)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: NL8501221
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NL8501221
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780072287
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: Integra® Pudenz Infant Cardiac Catheter Barium Impregnated Barium Stripe

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?
61158	Atrial cerebrospinal fluid catheter	A flexible tube intended to be implanted as the distal component of a ventriculoatrial shunt to channel cerebrospinal fluid (CSF) to the right atrium where it can be absorbed into the body. It is intended to be part of a therapeutic measure for situations where increased CSF causes elevated intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included.	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: Distal Tubing: 0.7 mm ID x 1.3 mm OD; Distal Tube Length: 9 cm; Proximal Tubing: 1.3 mm ID x 2.2mm OD; Total Length: 55 cm (22") (All dimensions nominal)

Device Record Status

Public Device Record Key: 35c5c998-b1d0-46fb-85e0-2e0cec29187c
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	M269NL85012211

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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