AccessGUDID - DEVICE: Valtchev Uterine Mobilizer (00627843701804)

GUDID

Device Identifier (DI) Information

Brand Name: Valtchev Uterine Mobilizer
Version or Model: 16A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16A
Company Name: Conkin Surgical Instruments Ltd

Primary DI Number: 00627843701804
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 257261032 *Terms of Use

Device Description: This attachment to the Valtchev Uterine Mobilizer model VUM-6 is a stainless steel cannula having a length of 83 mm and shaft thickness of 3 mm. The pin on the cannula must slip into the notch of the head of the VUM-6 base instrument. The cannula has no stand alone functionality and is either sold as part of the VUM-6 complete set or as a separate replacement part.

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):	No
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?
15677	Uterine elevator	A hand-held surgical instrument used to lift and manipulate the structure of the uterus to facilitate examination and surgery on this organ and/or the surrounding organs/tissue during a surgical intervention. It is typically a single-ended device with a blunted blade or hook with no cutting edges that can be of various shapes and a handle at the proximal end. It is usually made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKF	Cannula, Manipulator/Injector, Uterine

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
Length: 83 Millimeter

Device Record Status

Public Device Record Key: 9be95081-dea1-4528-8f59-4d57d6aa4a2a
Public Version Date: February 22, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2016