AccessGUDID - DEVICE: NA (04055207014875)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8370501
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8370.501
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207014875
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: UTERUS MANIPULATOR Ø 12MM WL 430MM for uterus fixation, distally angled, TL 659mm, with Luer connection, reusable

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?
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
HEW	Culdoscope (and accessories)

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 12 Millimeter
Length: 430 Millimeter

Device Record Status

Public Device Record Key: 8872a246-5707-4674-849c-3a8cd6c093c6
Public Version Date: May 26, 2023
Public Version Number: 6
DI Record Publish Date: September 26, 2016