AccessGUDID - DEVICE: PANOVIEW PLUS (04055207021934)

GUDID

Device Identifier (DI) Information

Brand Name: PANOVIEW PLUS
Version or Model: 8912402
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8912.402
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207021934
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: OP-ENDOSCOPE 0° Ø 10MM WL 267MM rigid, with parallel ocular lens, working channel Ø 5.1mm, TL 390mm, 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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Rigid optical laparoscope	An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

GMDN Preferred Term Name

GMDN Definition

Rigid optical laparoscope

An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

FDA Product Code

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Product Code	Product Code Name
GCM	ENDOSCOPE, RIGID

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 [?]
Hydrogen Peroxide
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Angle: 0 degree
Outer Diameter: 10 Millimeter
Length: 267 Millimeter

Device Record Status

Public Device Record Key: 9d32c3fc-723b-4feb-a836-57ea0bf77b8c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016