AccessGUDID - DEVICE: SHARK/S-LINE (04055207048900)

GUDID

Device Identifier (DI) Information

Brand Name: SHARK/S-LINE
Version or Model: 46230223
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4623.0223
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207048900
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: COAG ELECTRODE BIPO 24-26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 24/26, Fr, electrode shape: cylinder, wire Ø 1.2mm, fork color blue, stem color blue, PACK=3 PCS, for Shark and S-Line Resectoscopes, sterile, for single use

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:	Yes
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?
61872	Endoscopic electrosurgical electrode, bipolar, single-use	An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 77fe718e-d28c-425a-a073-1cf6d8e39010
Public Version Date: November 21, 2024
Public Version Number: 10
DI Record Publish Date: June 28, 2017