FDA.report

NA

Primary DI
40653405008249
Brand
NA
Company
Conmed Corporation
Model
60-0235-001
Catalog number
60-0235-001
Device description
ELECTROSURGICAL SAFETY HOLSTER
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40653405008249Direct MarkingGS10
20653405008245PackageGS110In Commercial Distribution
30653405008242PrimaryGS10
00653405008241Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4065340500824940653405008249
2065340500824520653405008245
3065340500824230653405008242
00653405008241006534050082416534050082410653405008241

GMDN Terms

TermDefinition
Electrosurgical handpiece/electrode holder, single-useA device intended to be used to house or fix an active electrosurgical handpiece/pen with its electrode when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. The holder will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags

DUNS number
071595540
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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