AccessGUDID - DEVICE: Key Surgical Electro Lube (00849771037873)

GUDID

Device Identifier (DI) Information

Brand Name: Key Surgical Electro Lube
Version or Model: EL-101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EL101
Company Name: KEY SURGICAL, INC.

Primary DI Number: 00849771037873
Issuing Agency: GS1
Commercial Distribution End Date: May 02, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 604056226 *Terms of Use

Device Description: Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.

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?
64097	Electrosurgical electrode lubricant	A solution intended to be applied to an electrosurgical electrode to help keep the distal tip of the electrode clean and free from debris during surgery by reducing tissue adhesion. It typically contains natural biocompatible phospholipids. After application this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033880	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 4 Milliliter

Device Record Status

Public Device Record Key: 4a7cc300-dee2-45ab-b483-4daaddb0fa8d
Public Version Date: May 05, 2025
Public Version Number: 4
DI Record Publish Date: September 11, 2019