O-ring Applicator Tool

Primary DI
00850071153101
Brand
O-ring Applicator Tool
Company
FOCUS SURGERY INC
Model
302-08119-1002
Device description
Sonablate HIFU O-ring Applicator Tool. This tool is intended to be included with the Sonablate Insertion Pack and Water Path Kit.
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850071153101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071153101008500711531018500711531010850071153101

GMDN Terms#

Term, Definition table
TermDefinition
Invasive ultrasound transducer cooling/coupling support kitA collection of devices intended to be used in conjunction with a non-surgically invasive ultrasound transducer (probe) (e.g., of a therapeutic oncological/gynaecological ultrasound system) to cool the transducer and improve coupling. It typically consists of a container(s) with fluid (e.g., water with dissolved polymers) which circulates between a heat exchanger and the transducer via connection tubing; it may also include coupling gel and devices intended to detect patient motion during the procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101084143
Device count
1
Kit
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
00868108000281Sonablate Insertion Pack403-02200-00022024-12-02
00868108000274Sonachill102-17000-00072016-09-28
00868108000267Sonablate Insertion Pack403-02200-00142017-03-24
00868108000212Sonasource102-17000-00092017-03-24
00868108000229Sonablate202-17000-00122017-03-24