AccessGUDID - DEVICE: NA (04055207001080)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8765621
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8765.621
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207001080
Issuing Agency: GS1
Commercial Distribution End Date: October 22, 2019
Device Count: 5
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: BUTTON ELECTRODE BIPO Ø 1.8MM SL 400MM for endoscopic spine surgery, flexible, PACK=5 PCS, 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?
61873	Endoscopic electrosurgical electrode, bipolar, reusable	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 (including 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). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, cutting & coagulation & accessories

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
Hydrogen Peroxide
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.8 Millimeter
Length: 400 Millimeter

Device Record Status

Public Device Record Key: b1ac8d68-90da-44dc-ab4a-ca1f941678e4
Public Version Date: November 21, 2024
Public Version Number: 5
DI Record Publish Date: September 23, 2016