Round Loop Electrode

Primary DI
00841494101701
Brand
Round Loop Electrode
Company
Ellman International
Model
TBBB/4
Catalog number
TBBB/4
Device description
5/32" RND LOOP ELEC. 4"L FINE WIRE,1/16"
Published
2016-09-21
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

Product Codes

CodeName
JOSElectrode, electrosurgical

Product Code Classifications

CodeDeviceSpecialtyClass
JOSElectrode, ElectrosurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841494101701PrimaryGS10
00841494105549Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494101701008414941017018414941017010841494101701
00841494105549008414941055498414941055490841494105549

GMDN Terms

TermDefinition
Open-surgery electrosurgical electrode, monopolar, reusableAn invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
079095245
Device count
2
DM exempt
true
Premarket exempt
true
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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00841494102388CORNEAL SHIELDH76AH76A2016-09-21
00841494102395CORNEAL SHIELDH75AH75A2016-09-21
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