AccessGUDID - DEVICE: NA (04055207019245)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8667961
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8667.961
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207019245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SCALPEL 20.5FR CERAMIC SEMICIRCULAR for optical urethrotome, telescope Ø 4mm, massive, 12 O'clock cutting position, for slitting of urethral (transurethral) and ureteral (percutaneous) stenosis, 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?
35141	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.	Active	false

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 6.83333333333 Millimeter

Device Record Status

Public Device Record Key: dc61a757-26b2-40ff-9f25-19aaff5ac54a
Public Version Date: January 25, 2023
Public Version Number: 6
DI Record Publish Date: September 23, 2016