AccessGUDID - DEVICE: Cutt. loop saline-resectoscopy electrode retrograde,24Ch. (EMAH3601024SL0)

GUDID

Device Identifier (DI) Information

Brand Name: Cutt. loop saline-resectoscopy electrode retrograde,24Ch.
Version or Model: 36.010.24SL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36.010.24SL
Company Name: mahe medical gmbh

Primary DI Number: EMAH3601024SL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342243334 *Terms of Use

Device Description: Cutt. loop saline-resectoscopy electrode retrograde,24Ch.

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?
42551	Electrosurgical return electrode, reusable	A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may be designed with permanently attached leads. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDC	RESECTOSCOPE, WORKING ELEMENT

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: 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: c2326449-6e6e-4572-8d7c-7caa1bbc8c48
Public Version Date: June 05, 2020
Public Version Number: 3
DI Record Publish Date: September 28, 2017