AccessGUDID - DEVICE: Cannula (07290114060400)

GUDID

Device Identifier (DI) Information

Brand Name: Cannula
Version or Model: Standard
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: STR-021621-00
Company Name: ALPHA OMEGA ENGINEERING CO. LTD.

Primary DI Number: 07290114060400
Issuing Agency: GS1
Commercial Distribution End Date: April 05, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 531856466 *Terms of Use

Device Description: Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet

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:	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?
61964	Intracerebral cannula, implantable	A sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It is made of synthetic polymer materials (e.g., polyurethane) and may include a stylet/trocar blade.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GZL	Electrode, Depth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120098	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: bf56c1a2-1979-478d-8f06-e963b3722f0e
Public Version Date: April 06, 2021
Public Version Number: 2
DI Record Publish Date: September 03, 2020