AccessGUDID - DEVICE: SUGITA ANEURYSM CLIP (04946329061338)

GUDID

Device Identifier (DI) Information

Brand Name: SUGITA ANEURYSM CLIP
Version or Model: 07-940-70
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07-940-70
Company Name: MIZUHO CORPORATION

Primary DI Number: 04946329061338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690677802 *Terms of Use

Device Description: TYPE: LARGE, PERMANENT, No.19A RANGE: 135-185gf(1.32-1.81N) MATERIAL: ISO 5832-7/ASTM F1058G2 BLADE: STRAIGHT MAXIMUM OPENING: 17.0mm GRIP SURFACE: SERRATED

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?
34958	Aneurysm clip	A metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is typically an alpha-shaped coil spring, with blades that open like jaws, that comes with a dedicated applier for application to the aneurysm. The device is available in a variety of sizes and its blades may be straight or curved. It is typically used to treat intracranial aneurysms; it may also be used to prevent bleeding from small blood vessels.	Active	true

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: 21 Millimeter

Device Record Status

Public Device Record Key: 94331ed0-bb07-4f5a-b256-a20d6d10cd05
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: October 10, 2015