FDA.report

Jac-cell Medic

Primary DI
B460JA15201
Brand
Jac-cell Medic
Company
9001-2030 Québec Inc
Model
JA-1520
Device description
Disposal standard blade electrode
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B460JA15201PrimaryHIBCC0

GMDN Terms

TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods

Method

Regulatory Flags

DUNS number
253086045
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B460ATI014A0Jac-cell MedicATI-014A2017-04-03
B460ATI0210Jac-cell MedicATI-0212017-04-03
B460JA11591Jac-cell Medic Inc.JA-11592016-12-22
B460JA11601Jac-cell Medic Inc.JA-11602016-12-22
B460JA11681Jac-cell Medic Inc.JA-11682016-12-22

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08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD8800290Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD881190Surgical DirectSurgical Direct, Inc.GEI2026-03-09