AccessGUDID - DEVICE: Sugita AVM Micro Clip Single Shaft Applier (04946329377484)

GUDID

Device Identifier (DI) Information

Brand Name: Sugita AVM Micro Clip Single Shaft Applier
Version or Model: 07-935-46
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07-935-46
Company Name: MIZUHO CORPORATION

Primary DI Number: 04946329377484
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690677802 *Terms of Use

Device Description: Sugita AVM Micro Clip Single Shaft Applier 150mm, Str, w/o Catches

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:	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?
32591	Aneurysm clip applier	A surgical instrument designed for the application/insertion of aneurysm clips (devices for approximating the edges of the neck of an aneurysm or for the prevention of bleeding from small individual blood vessels). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCI	Applier, Aneurysm Clip

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 304 Millimeter

Device Record Status

Public Device Record Key: cd68c829-cd97-4956-b76e-0bd9b594b2bb
Public Version Date: October 14, 2020
Public Version Number: 1
DI Record Publish Date: October 06, 2020