AccessGUDID - DEVICE: E-LINE (04055207045558)

GUDID

Device Identifier (DI) Information

Brand Name: E-LINE
Version or Model: 86520347
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8652.0347
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207045558
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: OBTURATOR FOR CYSTOSCOPE 19.5FR color code red, WL 230mm, oval, rounded distal end, compatible with sheath 86520345, 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
FBO	CYSTOURETHROSCOPE

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
Moist Heat or Steam Sterilization
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 6.5 Millimeter

Device Record Status

Public Device Record Key: 6a21fc9d-160b-407f-94fe-b3c3a3712c73
Public Version Date: May 29, 2023
Public Version Number: 6
DI Record Publish Date: September 26, 2016