AccessGUDID - DEVICE: Edge (10884524002217)

GUDID

Device Identifier (DI) Information

Brand Name: Edge
Version or Model: E2350HGNSB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884524002217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1800
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Rocker Switch Pencil Blade Electrode, Holster; Caution: For manufacturing, processing, or repacking.

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):	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?
57944	Endoscopic electrosurgical handpiece/electrode, bipolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use 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 [?]
K955836	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry
Handling Environment Temperature: between -22 and 140 Degrees Fahrenheit
Handling Environment Humidity: between 0 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Feet

Device Record Status

Public Device Record Key: 266610cd-7c38-4462-a85a-bbc149fd9dbe
Public Version Date: May 12, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016