AccessGUDID - DEVICE: TIPCONTROL (04055207054215)

GUDID

Device Identifier (DI) Information

Brand Name: TIPCONTROL
Version or Model: 4993692
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4993692
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207054215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: RF INSTRUMENT BIPO Ø 2.5MM WL 350MM for endoscopic spine surgery, flexible insert, integrated connection cable WL 3m with device plug to Radioblator RF 4MHz, 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
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: 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 33 Degrees Celsius
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.5 Millimeter
Length: 350 Millimeter

Device Record Status

Public Device Record Key: bd449b42-0426-445a-8be8-6d5d059bdd13
Public Version Date: November 21, 2024
Public Version Number: 3
DI Record Publish Date: March 01, 2024