AccessGUDID - DEVICE: Novo Surgical (00842331121647)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: NSFE782K
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331121647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: clip yasargil, standard, permanent, curved, 8.7 mm maximum opening, 15 mm blade length, 1.88N closing force, 200g force

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?
63437	Aneurysm clip, non-sterile	A non-sterile, 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HCH	Clip, Aneurysm

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: 15 Millimeter

Device Record Status

Public Device Record Key: 700a671e-d2cd-4431-ba91-14644b1eafa2
Public Version Date: May 14, 2019
Public Version Number: 1
DI Record Publish Date: May 06, 2019