AccessGUDID - DEVICE: PANOVIEW PLUS (04055207023433)

GUDID

Device Identifier (DI) Information

Brand Name: PANOVIEW PLUS
Version or Model: 8968405
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8968405
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207023433
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: NEPHROSCOPE 12° 8.5/12.3FR WL 250MM rigid, with lateral ocular lens, working channel for instruments up to 6Fr, TL 383mm, rod lens system

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?
15290	Rigid optical nephroscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the kidney. It is inserted percutaneously into the renal pelvis during nephroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the internal structures of the kidney and may be used in the removal of renal calculi. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGA	Kit, nephroscope

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 250 Millimeter
Angle: 12 degree

Device Record Status

Public Device Record Key: 172c6aff-e787-4045-b5d5-80a2569d2bab
Public Version Date: February 29, 2024
Public Version Number: 7
DI Record Publish Date: September 23, 2016