AccessGUDID - DEVICE: CODMAN CERTAS® Plus (10381780529538)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN CERTAS® Plus
Version or Model: 828826PL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82-8826PL
Company Name: Integra LifeSciences Switzerland Sàrl

Primary DI Number: 10381780529538
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480186617 *Terms of Use

Device Description: CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with SIPHONGUARD® ,Accessories and Unitised Catheter

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?
61123	Ventriculo-peritoneal/atrial shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. 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: Do Not Use if Package is Damaged

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1e5ab931-eb5d-4824-b95c-6a714063d163
Public Version Date: March 17, 2025
Public Version Number: 6
DI Record Publish Date: June 02, 2020