AccessGUDID - DEVICE: ShuntPen Cannula (B0672120C1)

GUDID

Device Identifier (DI) Information

Brand Name: ShuntPen Cannula
Version or Model: 2120C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2120C
Company Name: CLARUS MEDICAL, LLC

Primary DI Number: B0672120C1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 010316284 *Terms of Use

Device Description: ShuntPen Cannula, to be used with Clarus 3000N Flexible Fiberoptic Endoscope.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
61491	Neuroscopic shunt placement kit	A collection of sterile devices intended to be used to implant an intracerebral ventricular catheter in a brain ventricle to function as a component of a ventriculo-peritoneal/atrial shunt for diversion of excessive cerebrospinal fluid (CSF) from the brain. The kit includes the catheter and a single-use rigid neuroscope intended for visual placement of the catheter; additional devices dedicated to catheter introduction/function (e.g., stylet) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GWG	Endoscope, Neurological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942249	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: 6a3a5f09-0a83-4ec6-9ef9-00ff2421fe99
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: B0672120C0 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 763-525-8400
Email: admin@clarus-medical.com

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