AccessGUDID - DEVICE: NA (04055207044995)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8982015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8982.015
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207044995
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: VAGINOSCOPE-TUBE ID 5MM OD 6MM for adults, TL 85mm, distal end straight, reusable

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?
15630	Vaginoscope	A hand-held endoscope intended to be used for the examination of the vagina, usually in children, typically when searching for foreign bodies or sources of bleeding. It typically includes an optical vaginal speculum and magnification device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOK	VAGINOSCOPE AND ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 5 Millimeter
Outer Diameter: 6 Millimeter

Device Record Status

Public Device Record Key: ed69aed4-3df4-4027-85a9-3042e1fef6d3
Public Version Date: November 03, 2023
Public Version Number: 5
DI Record Publish Date: September 28, 2016