AccessGUDID - DEVICE: CODMAN® (10381780511557)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN®
Version or Model: 161056
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 16-1056
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780511557
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 5
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: CODMAN® SOOTT Ventricular Cannula Disposable 8Fr. 1.3mm I D x 2.5mm O D 100mm

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?
61854	Intracerebral cannula, nonimplantable, reusable	A nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCA	CATHETER, VENTRICULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K834477	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
Length: 100 Millimeter
Catheter Gauge: 8 French
Outer Diameter: 2.5 Millimeter
Device Size Text, specify: 1.3mm Inner Diameter

Device Record Status

Public Device Record Key: d123fa02-0249-4b35-a1f7-7b505efccd01
Public Version Date: March 25, 2024
Public Version Number: 6
DI Record Publish Date: April 01, 2020