AccessGUDID - DEVICE: Novo Surgical (G586OB4390110)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: OB4390-11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OB4390-11
Company Name: NOVO SURGICAL, INC.

Primary DI Number: G586OB4390110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: zep-type parametrium scissors, novocut™, tungsten carbide, serrated, fully curved, 9" (23.0 cm)

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?
35328	Gynaecological scissors, reusable	A hand-held manual surgical instrument designed to cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. It is comprised of two pivoted shearing blades with finger and thumb ring-handles (i.e., not pinch-grip design) whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may have carbide inserts along the cutting edges. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRW	Scissors, General, Surgical

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: 648b1458-9eb3-477a-9e78-b661b003297d
Public Version Date: December 27, 2023
Public Version Number: 1
DI Record Publish Date: December 19, 2023