Sonablate Insertion Pack 403-14500-0003-BG

GUDID 00850071153125

FOCUS SURGERY INC

Invasive ultrasound transducer cooling/coupling support kit
Primary Device ID00850071153125
NIH Device Record Key49b03667-4295-4985-a36a-28b1419c05a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonablate Insertion Pack
Version Model Number403-02200-0002-BG
Catalog Number403-14500-0003-BG
Company DUNS101084143
Company NameFOCUS SURGERY INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850071153125 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-29
Device Publish Date2025-09-19

On-Brand Devices [Sonablate Insertion Pack]

00868108000267A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit
00868108000281A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit.
00850071153095403-02200-0002-I
00850071153071403-02200-0014-I
00850071153125403-02200-0002-BG

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