AccessGUDID - DEVICE: CODMAN® CERTAS® Plus (10381780535393)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN® CERTAS® Plus
Version or Model: 828803PL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82-8803PL
Company Name: Integra LifeSciences Switzerland Sàrl

Primary DI Number: 10381780535393
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480186617 *Terms of Use
Previous DI: 10381780521136

Device Description: CODMAN® CERTAS® Plus Programmable Valve Inline Valve with Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual

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:	Yes
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?
35965	Cerebrospinal fluid shunt valve	An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HCA	CATHETER, VENTRICULAR
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, Keep away from sunlight
Handling Environment Temperature: between 2 and 27 Degrees Celsius
Handling Environment Temperature: between 36 and 81 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 27 Degrees Celsius
Storage Environment Temperature: between 36 and 81 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a01aaf1d-3ad3-4fb4-9100-6850ac1d8e73
Public Version Date: July 01, 2025
Public Version Number: 3
DI Record Publish Date: November 20, 2024