AccessGUDID - DEVICE: Novo Surgical (G586N96849620)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: N96849-62
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N96849-62
Company Name: NOVO SURGICAL, INC.

Primary DI Number: G586N96849620
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: zenith bucy cordotomy knife, 1/2" (6.0 mm) blade, 6-1/2" (16.5 cm), forward cutting

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?
35135	Dura mater knife	A hand-held manual surgical instrument designed to cut or incise the dura mater without damaging the underlying structures during a surgical intervention. It is typically a one-piece instrument with a sharp, single-edged, cutting blade terminating in a hook shape at the distal end (the internal radius of the hook has the cutting edge) which is normally very small; it has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	INSTRUMENT, SURGICAL, NON-POWERED

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: fc7e54f2-d7fd-46e6-b8f0-701fc909a5a5
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023