S-1510-B-18

GUDID 15415067028478

Radiofrequency Cannula - Straight Blunt

ST. JUDE MEDICAL, INC.

Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation system probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use Percutaneous radio-frequency ablation probe cannula, single-use
Primary Device ID15415067028478
NIH Device Record Key8ab7d111-b20c-402a-98f3-3e5b2aea3c81
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCLASSIC
Catalog NumberS-1510-B-18
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter
Needle Gauge18 Gauge
Length15 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry place; avoid exposure to extreme temperatures

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067028471 [Primary]
GS115415067028478 [Package]
Contains: 05415067028471
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXIPROBE, RADIOFREQUENCY LESION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-10

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