FDA.report

NA

Primary DI
05415067028808
Brand
NA
Company
ST. JUDE MEDICAL, INC.
Model
SMK-S1510-20
Catalog number
SMK-S1510-20
Device description
Radiofrequency Cannula - Straight
Published
2017-04-10
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

Contact Domains

Product Codes

CodeName
GXIPROBE, RADIOFREQUENCY LESION

Product Code Classifications

CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15415067028805PackageGS110In Commercial Distribution
05415067028808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1541506702880515415067028805
05415067028808054150670288085415067028808

GMDN Terms

TermDefinition
Radio-frequency ablation system probe cannula, single-useA sterile rigid tube designed to provide body tissue access through its lumen for a radio-frequency (RF) probe during RF ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

Device Sizes

TypeValueUnit
Length15Centimeter
Needle Gauge20Gauge

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool and dry place; avoid exposure to extreme temperatures

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags

DUNS number
149818952
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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