AccessGUDID - DEVICE: E-LINE (04055207010037)

GUDID

Device Identifier (DI) Information

Brand Name: E-LINE
Version or Model: 841511
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8415.11
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207010037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: VIEWING OBTURATOR RESECTOSCOPE 22FR color code green, WL 232mm, rounded distal end, compatible with E-Line sheaths 8654064, 8663064, 8655344, 8655144, and telescopes Ø 4mm, 0°/12°/30°, 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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

[?]

Product Code	Product Code Name
FJL	RESECTOSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980302	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 7.33333333333 Millimeter

Device Record Status

Public Device Record Key: c1c9bc21-e2d3-499d-9ffc-564edaba4aca
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 2016