AccessGUDID - DEVICE: PANOVIEW (04055207055113)

GUDID

Device Identifier (DI) Information

Brand Name: PANOVIEW
Version or Model: 8970407
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8970407
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207055113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: MORCESCOPE 0° 24FR WL 199MM rigid, with parallel ocular lens, working channel for instruments up to 4.8mm, irrigation via 24.5/26Ch sheath and attachement, suction via morcellator, TL 393mm, 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?
37084	Rigid endoscope telescope	An optical device designed to provide the illumination and image transmission capabilities of a rigid endoscope. It typically includes a set of lenses (e.g., thin and rod-shaped lenses) and/or a fibreoptic bunch, and is introduced though the sheath of the endoscope (e.g., a rigid cystoscope or resectoscope). The endoscopic telescope is connected proximally to a light source, and the returning image is directly observed or scanned with a video camera. Dedicated types are available for direct, lateral, and oblique views. It is used for examination of body cavities following natural tracts (e.g., urinary, gastrointestinal) or surgical cavities (e.g., laparoscopic). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FJL	Resectoscope

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: 199 Millimeter
Outer Diameter: 8 Millimeter
Angle: 0 degree

Device Record Status

Public Device Record Key: ab3ed5d4-c03a-4500-96db-dee525aa0e73
Public Version Date: November 21, 2024
Public Version Number: 2
DI Record Publish Date: August 03, 2023