AccessGUDID - DEVICE: ValveGate™ Endoscope 5mm, direction of view 30°, autoclavable, 30cm (04057034117071)

GUDID

Device Identifier (DI) Information

Brand Name: ValveGate™ Endoscope 5mm, direction of view 30°, autoclavable, 30cm
Version or Model: 34-0961.AC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 34-0961.AC
Company Name: Geister Medizintechnik GmbH

Primary DI Number: 04057034117071
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343548848 *Terms of Use

Device Description: ValveGate™ Endoscope 5mm, direction of view 30°, autoclavable, 30cm

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":	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?
32043	Laparoscopic surgical procedure kit, non-medicated, reusable	A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

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
No Device Sizes

Device Record Status

Public Device Record Key: 9e3f36bc-cd10-4968-86f6-3e321caa8196
Public Version Date: October 19, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016