AccessGUDID - DEVICE: Uterine ElevatOR Pro with OccludOR Balloon (09349967003299)

GUDID

Device Identifier (DI) Information

Brand Name: Uterine ElevatOR Pro with OccludOR Balloon
Version or Model: UE-OBPRO-32
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THE O R COMPANY PTY LTD

Primary DI Number: 09349967003299
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 744346235 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
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?
58051	Uterine manipulator, single-use	A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use 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: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 32 Millimeter

Device Record Status

Public Device Record Key: 4a99a9f4-54a6-4d87-b6db-7d0d540db286
Public Version Date: April 04, 2023
Public Version Number: 2
DI Record Publish Date: March 07, 2019