Key Surgical Electro Lube

GUDID 10849771037870

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

KEY SURGICAL, INC.

Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant Electrosurgical electrode lubricant
Primary Device ID10849771037870
NIH Device Record Key4a7cc300-dee2-45ab-b483-4daaddb0fa8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameKey Surgical Electro Lube
Version Model NumberEL-101
Company DUNS604056226
Company NameKEY SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone8005417995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com
Phone+1(800)541-7995
Emailquality@keysurgical.com

Device Dimensions

Total Volume4 Milliliter
Total Volume4 Milliliter
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Device Identifiers

Device Issuing AgencyDevice ID
GS100849771037873 [Primary]
GS110849771037870 [Package]
Contains: 00849771037873
Package: Box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-19
Device Publish Date2019-09-11

Devices Manufactured by KEY SURGICAL, INC.

00849771047513 - NA2024-06-07 Instrument Stringer, Surgical stainless steel, 4-inch x 2.75-inch
00849771047643 - NA2024-04-01 Instrument Stringers, Center Lock Stringer, Surgical Stainless Steel, 6-inch x 3-inch
00849771048077 - NA2024-04-01 German Stainless Steel Pliers, Locking Pliers, 8-inch medium
00849771048220 - NA2024-04-01 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 12-inch long
00849771048244 - NA2024-04-01 K-Wire and Steinmann Pin Dispensers, 3/32-inch (2.4mm) diameter, Holds pins up to 12-inch long
10849771050473 - NA2024-04-01 Suture Booties, White, Sterile, 5 pair per pad
00849771051275 - NA2024-04-01 Endoscope Brush, 150cm long, 4.2mm dia, 2cm BAL, Nylon Bristles, pink polypropylene tubing
00849771051534 - Key Surgical Endoscope Brushes2024-04-01 Specialty Cleaning Brushes, nylon, ss spring coil wire, 3-5mm tapered, bead

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