FDA.reportPublic FDA data

Sonablate Insertion Pack

Primary DI
00868108000267
Brand
Sonablate Insertion Pack
Company
FOCUS SURGERY INC
Model
403-02200-0014
Device description
A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit
Published
2017-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLPHigh Intensity Ultrasound System For Prostate Tissue AblationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868108000267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868108000267008681080002678681080002670868108000267

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic hyperthermia systemAn assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101084143
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850071153125Sonablate Insertion Pack403-02200-0002-BG403-14500-0003-BG2025-09-19
00850071153255Sonablate System711-17000-00092025-08-22
00850071153064Water Path KitE01020AST61-I2024-12-09
00850071153071Sonablate Insertion Pack403-02200-0014-I2024-12-09
00850071153088Water Path Kit403-02200-0020-I2024-12-09
00850071153095Sonablate Insertion Pack403-02200-0002-I2024-12-09
00868108000298Water Path Kit403-02200-00202024-12-09
00868108000205Water Path KitE01020AST612024-12-07
00850071153101O-ring Applicator Tool302-08119-10022024-12-02
00868108000281Sonablate Insertion Pack403-02200-00022024-12-02
00868108000274Sonachill102-17000-00072016-09-28
00868108000212Sonasource102-17000-00092017-03-24
00868108000229Sonablate202-17000-00122017-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03661690000342Endorectal ProbeEDAP-TMS FRANCEPLP2026-01-26
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07540281001721TULSA-PROProfound Medical IncPLP2023-10-24
07290019402268EXABLATE PROSTATE Treatment master kit for V2.2INSIGHTEC LTDPLP2022-12-15
07540281001547TULSA-PROProfound Medical IncPLP2022-11-30
07540281001554TULSA-PROProfound Medical IncPLP2022-11-30
07540281001561TULSA-PROProfound Medical IncPLP2022-11-30
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07540281001684TULSA-PROProfound Medical IncPLP2022-11-30
07540281001691TULSA-PROProfound Medical IncPLP2022-11-30
07540281001615TULSA-PROProfound Medical IncPLP2022-11-24
07540281001370TULSA-PROProfound Medical IncPLP2022-09-23
07540281001400TULSA-PROProfound Medical IncPLP2022-09-23
07540281000816TULSA-PROProfound Medical IncPLP2022-05-26
07540281000823TULSA-PROProfound Medical IncPLP2022-05-26
07540281000830TULSA-PROProfound Medical IncPLP2022-05-26
07540281000847TULSA-PROProfound Medical IncPLP2022-05-26
07540281000908TULSA-PRO Profound Medical IncPLP2022-05-26
07540281001196TULSA-PROProfound Medical IncPLP2022-05-26
07540281001233TULSA-PRO Profound Medical IncPLP2022-05-26
07540281001240TULSA-PROProfound Medical IncPLP2022-05-26