AccessGUDID - DEVICE: Novo Surgical (G586UR96225190)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: UR96225-19
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UR96225-19
Company Name: NOVO SURGICAL, INC.

Primary DI Number: G586UR96225190
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: zenith desjardins gall stone scoops, flexible shafts, 11-3/4" (26.0 cm), 24 fr. (8.0 mm)

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?
13509	Gallstone scoop	A hand-held manual surgical instrument designed for the removal of gallstones. It is typically made of high-grade stainless steel and has a very long, thin, malleable (bendable) working end that terminates in a small spoon-like scoop. At the proximal end is a handle used by the surgeon to manipulate and operate the instrument during the removal procedure. It can have a variety of scoop designs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHL	SCOOP

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: 47ab2998-8faa-48f6-8f74-b3f11b9b9dd7
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023