FDA.reportPublic FDA data

SonoVision

Primary DI
00860001239386
Brand
SonoVision
Company
Tissue Differentiation Intelligence LLC
Model
100034
Device description
SonoVision Accessory Kit Second Dilator
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001239386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001239386008600012393868600012393860860001239386

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access kit, reusableA collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile; handle with care
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081327336
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001239324SonoVision1000212022-12-08
00860001239331SonoVision1000222022-12-08
00860001239362SonoVision1000302022-12-08
00860001239379SonoVision1000332022-12-08
00860001239300SonoVision1000392022-11-03
00860001239348Beluga11000052022-03-03
00860001239355SonoVision1000092022-03-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
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