AccessGUDID - DEVICE: CODMAN CERTAS® Plus (10381780529293)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN CERTAS® Plus
Version or Model: 828827PL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82-8827PL
Company Name: Integra LifeSciences Switzerland Sàrl

Primary DI Number: 10381780529293
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 BACTISEAL® 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: 164b8bb7-1ae1-4309-b2df-ee2adf3ebdd0
Public Version Date: March 17, 2025
Public Version Number: 8
DI Record Publish Date: June 02, 2020