AccessGUDID - DEVICE: E-LINE (04055207045565)

GUDID

Device Identifier (DI) Information

Brand Name: E-LINE
Version or Model: 86520445
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8652.0445
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207045565
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SHEATH FOR CYSTOSCOPE 21FR color code blue, SL 209mm, oval, slanted distal end, capacity for instruments up to 10Fr or 2x 6Fr, compatible with attachments 8652254, 8652264, 8652.284, and telescopes Ø 4mm, with 2 flushing ports, quick-lock, 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 sheath, reusable	A component of a rigid endoscope assembly designed as a tube through which an endoscope and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Rigid endoscope sheath, reusable

A component of a rigid endoscope assembly designed as a tube through which an endoscope and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
FBO	CYSTOURETHROSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011496	000

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: 7 Millimeter

Device Record Status

Public Device Record Key: 2533a6dc-131b-4941-9a9f-f4869bab58af
Public Version Date: July 24, 2018
Public Version Number: 4
DI Record Publish Date: September 26, 2016