AccessGUDID - DEVICE: NA (04055207019788)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8677931
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8677931
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207019788
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SCALPEL 14.5FR SICKLE SHAPED for small caliber resectoscope, telescope Ø 2.7mm, cutting position 6 O'clock, for cutting urethral strictures, 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
Scalpel, reusable	A hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
EZO	Urethrotome

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: 4.83333333333 Millimeter

Device Record Status

Public Device Record Key: d07dc3c6-c59a-4e6d-a1c8-27f8f1166915
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016