AccessGUDID - DEVICE: SHARK/S-LINE (04055207018026)

GUDID

Device Identifier (DI) Information

Brand Name: SHARK/S-LINE
Version or Model: 8622133
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8622133
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207018026
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: CUTTING ELECTRODE BIPO 22FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, continuous irrigation, 22/24, Fr, loop: round, wire Ø 0.3mm, fork color blue, stem color yellow, PACK=1 PC, for Shark and S-Line Resectoscopes, unsterile, 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?
32684	Endoscopic electrosurgical handpiece/electrode, bipolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

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: 7.33333333333 Millimeter

Device Record Status

Public Device Record Key: ab9add93-c5ce-4484-9964-da935de25d73
Public Version Date: February 29, 2024
Public Version Number: 7
DI Record Publish Date: September 27, 2016