AccessGUDID - DEVICE: Viper reusable (EAMIEVI10100)

GUDID

Device Identifier (DI) Information

Brand Name: Viper reusable
Version or Model: EVI1010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EVI1010
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMIEVI10100
Issuing Agency: HIBCC
Commercial Distribution End Date: September 30, 2022
Device Count: 5
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

Device Description: No description.

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):	Yes
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?
62061	Endoscopic electrosurgical electrode, monopolar, reusable	An 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 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/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. 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 [?]
K182013	000

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
Length: 45 Millimeter
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: c23a5afa-56b6-4c26-a789-e4bae7a081ed
Public Version Date: October 04, 2022
Public Version Number: 2
DI Record Publish Date: April 05, 2019