AccessGUDID - DEVICE: CODMAN HOLTER (10886704040767)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN HOLTER
Version or Model: 82-1697
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 821697
Company Name: Cerenovus, Inc.

Primary DI Number: 10886704040767
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: CODMAN HOLTER In-Line Shunt Filter, Hoffman Design

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?
15688	Cerebrospinal fluid shunt filter	A sterile implantable device intended to be used with a cerebrospinal fluid (CSF) shunt assembly (e.g., ventriculoperitoneal shunt, lumboperitoneal shunt) for in-line shunt placement to filter particles by size to prevent transmission of cells when draining CSF from the brain. It typically includes a cellulose membrane supported in a stainless steel mesh encased in, e.g., silicone, and has ports for connection to the shunt. It is used when neoplasms are present or suspected in patients who need treatment using a CSF shunt. It may be implanted behind the mastoid air cells to expose its content to radiation when applied.	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 [?]
K102961	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8c93c130-0208-4a5f-a665-0466502f9dc0
Public Version Date: September 15, 2023
Public Version Number: 5
DI Record Publish Date: September 20, 2015