AccessGUDID - DEVICE: E-LINE (04055207018286)

GUDID

Device Identifier (DI) Information

Brand Name: E-LINE
Version or Model: 8650204
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8650.204
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207018286
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: WORKING INSERT FOR CYSTOSCOPE 0/30/70 with Albarran-lever, compatible with sheaths 86500245, 86500345, 86500445, 86500545, and telescopes Ø 4mm, with 2 introduction ports, bayonet-cap, 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?
37085	Rigid endoscope working guide	An endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. 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 [?]
Moist Heat or Steam Sterilization

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: 07a3af29-7ea5-4707-8d5d-7d135eb30b8e
Public Version Date: April 27, 2021
Public Version Number: 7
DI Record Publish Date: September 27, 2016