DEVICE: RZ Medizintechnik GmbH (04049197272100)
Device Identifier (DI) Information
RZ Medizintechnik GmbH
350-660-116
In Commercial Distribution
350-660-116
RZ-Medizintechnik GmbH
350-660-116
In Commercial Distribution
350-660-116
RZ-Medizintechnik GmbH
Adaptor 3,2x45 mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
565f93a4-aee6-4f65-ae94-2c66e83ff2f6
September 30, 2024
1
September 20, 2024
September 30, 2024
1
September 20, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49746294700
info@rz-medizintechnik.com
info@rz-medizintechnik.com