FDA.report

NA

Primary DI
00813250012910
Brand
NA
Company
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Model
RFK-C51016S
Device description
Cannula, 5cm, 10mm tip, 16G Sharp Curved
Published
2017-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GXIPROBE, RADIOFREQUENCY LESION

Product Code Classifications

CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813250012910PackageGS110In Commercial Distribution
00813250012958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813250012910008132500129108132500129100813250012910
00813250012958008132500129588132500129580813250012958

GMDN Terms

TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
824951958
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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