AccessGUDID - DEVICE: SHARK (04055207049037)

GUDID

Device Identifier (DI) Information

Brand Name: SHARK
Version or Model: 46782235
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 46782235
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207049037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: CUTTING ELECTRODE MONO 22FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, continuous irrigation, 22/24 Fr, loop: round, wire Ø 0.35 mm, fork color green, stem color transparent, PACK = 10 PCS, for Shark Resectoscope, 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?
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact 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 ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 7.33333333333 Millimeter

Device Record Status

Public Device Record Key: 8b7197c4-80f0-4226-b9c3-6cf89834e986
Public Version Date: December 02, 2024
Public Version Number: 9
DI Record Publish Date: June 28, 2017