FDA.reportPublic FDA data

Key Surgical Electro Lube

Primary DI
00849771037873
Brand
Key Surgical Electro Lube
Company
KEY SURGICAL, INC.
Model
EL-101
Catalog number
EL101
Device description
Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
Published
2019-09-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033880000ELECTRO-LUBEMectra Labs, Inc.2004-03-10GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849771037870PackageGS120Not in Commercial Distribution
00849771037873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977103787010849771037870
00849771037873008497710378738497710378730849771037873

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical electrode lubricantA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4Milliliter

Contacts#

Phone, Email table
PhoneEmail
+1(800)541-7995quality@keysurgical.com

Regulatory Flags#

DUNS number
604056226
Device count
1
Lot or batch
true
Expiration date on label
true

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00849771048367NASurgical Plastic InstrumentKS3472023-01-26
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