AccessGUDID - DEVICE: IEC-Innoview GmbH (B192300514000)

GUDID

Device Identifier (DI) Information

Brand Name: IEC-Innoview GmbH
Version or Model: 30-0514-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30-0514-00
Company Name: INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.

Primary DI Number: B192300514000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010741028 *Terms of Use

Device Description: Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 12deg., Lateral offset Eyepiece (Marberger), L=430 mm, autoclavable

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?
36654	Rigid optical ureteroscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter, (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGB	Ureteroscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062707	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 7.5 French
Length: 430 Millimeter
Angle: 12 degree
Catheter Gauge: 6.0 French

Device Record Status

Public Device Record Key: 31776827-e51a-4a70-a31c-decd9b23d05e
Public Version Date: November 17, 2023
Public Version Number: 4
DI Record Publish Date: May 26, 2016