AccessGUDID - DEVICE: CODMAN® CERTAS™ Plus (10381780532897)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN® CERTAS™ Plus
Version or Model: 828852
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82-8852
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780532897
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: CODMAN® CERTAS® Plus Electronic Tool Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
44856	Cerebrospinal fluid shunt valve programmer	A device intended to noninvasively modify the operating pressure of a programmable, non-active, implanted hydrocephalic valve that will be part of a hydrocephalic shunt system. It is used in neurosurgery for intra- and postoperative treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It typically includes electronic circuits, a control panel, a programming information display, and transmitter/identification devices (e.g., smart cards). When externally placed on the location of the implanted valve, it is actuated to supply coded magnetic signals to affect mechanical changes to the pressure characteristics of the proprietary implanted valve.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181902	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Waste from Electrical and Electronic Equipment; Handling Environment Atmospheric Pressure in kPa (High) 101.3; Storage Environment Atmospheric Pressure in kPA (High) 101.3
Handling Environment Atmospheric Pressure: more than 60 KiloPascal
Storage Environment Temperature: between -30 and 60 Degrees Celsius
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -22 and 140 Degrees Fahrenheit
Handling Environment Temperature: between -22 and 140 Degrees Fahrenheit
Handling Environment Temperature: between -30 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: more than 60 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fbffdef6-f61b-4eca-8ec1-f8fab7cc18b4
Public Version Date: May 16, 2023
Public Version Number: 4
DI Record Publish Date: April 30, 2020