AccessGUDID - DEVICE: NA (04055207018958)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8655314
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8655314
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207018958
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: OUTER SHEATH LASER THERAPY 24.5FR color code green, SL 191 mm, round, non-rotatable, distal end straight, continuous irrigation, compatible with inner sheath 8655324, and telescopes Ø 4 mm, 12°/30°, with irrigation stopcock, E-Line quick connection, 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?
37086	Endoscope sheath, reusable	A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDC	RESECTOSCOPE, WORKING ELEMENT

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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 8.16666666666 Millimeter

Device Record Status

Public Device Record Key: f615c6c4-e73f-4fa7-9fc7-98d426042c64
Public Version Date: December 02, 2024
Public Version Number: 8
DI Record Publish Date: September 23, 2016