AccessGUDID - DEVICE: Uretero-Renoscope,425mm,rigid,distal end 6/7.5Ch., work.channel 4Ch. (EMAH35003060)

GUDID

Device Identifier (DI) Information

Brand Name: Uretero-Renoscope,425mm,rigid,distal end 6/7.5Ch., work.channel 4Ch.
Version or Model: 35.003.06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 35.003.06
Company Name: mahe medical gmbh

Primary DI Number: EMAH35003060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342243334 *Terms of Use

Device Description: Uretero-Renoscope,425mm,rigid,distal end 6/7.5Ch., work.channel 4Ch. direct.of view 8° to working channel

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
35301	Resectoscope	An endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

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
Length: 425.0 Millimeter

Device Record Status

Public Device Record Key: 15e0463d-76ac-46ba-bc81-a9434329b6e7
Public Version Date: January 10, 2019
Public Version Number: 1
DI Record Publish Date: December 10, 2018