AccessGUDID - DEVICE: RZ Medizintechnik GmbH (04049197272100)

GUDID

Device Identifier (DI) Information

Brand Name: RZ Medizintechnik GmbH
Version or Model: 350-660-116
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 350-660-116
Company Name: RZ-Medizintechnik GmbH

Primary DI Number: 04049197272100
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312953227 *Terms of Use

Device Description: Adaptor 3,2x45 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":	Yes
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?
63994	Uterine manipulator, reusable	A hand-held, manually-operated, surgical instrument designed to mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopic hysterectomy), to enable uterine control and improved visibility of the pelvic anatomy. The device typically consists of a probe which is positioned within an introduction sheath/handpiece and includes an illuminator for transillumination of the uterus/cervix during laparoscopy (through the diaphanoscopy effect); it typically includes a suction line (for aspiration and/or tissue retention/manipulation). This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 565f93a4-aee6-4f65-ae94-2c66e83ff2f6
Public Version Date: September 30, 2024
Public Version Number: 1
DI Record Publish Date: September 20, 2024