AccessGUDID - DEVICE: NA (04055207045046)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8982037
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8982.037
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207045046
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: OBTURATOR FOR VAGINOSCOPE OD 8.8MM for WL 135mm, compatible with vaginal scope tube 8982035, 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?
35692	Rigid endoscope obturator	An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. 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 [?]
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
Outer Diameter: 8.8 Millimeter

Device Record Status

Public Device Record Key: 91ce957c-fa41-4408-915e-19800ef014cd
Public Version Date: May 26, 2023
Public Version Number: 4
DI Record Publish Date: September 28, 2016