FDA.reportPublic FDA data

Clean Ultrasound Probe Cover

Primary DI
09350855000290
Brand
Clean Ultrasound Probe Cover
Company
NANOSONICS LIMITED
Model
N00102
Published
2019-07-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FFFCover, Biopsy Forceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFFCover, Biopsy ForcepsGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350855000290PrimaryGS10
09350855000405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350855000290093508550002909350855000290
09350855000405093508550004059350855000405

GMDN Terms#

Term, Definition table
TermDefinition
Electronic device storage cover, single-useA non-sterile device intended to cover a portable electronic medical device while it is not in use to protect it from damage/contamination. The cover is often shaped for a specific type of portable electronic device and is intended to be removed before electronic device use. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
741021943
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350855000580CORIS QUANTUM Cleaning AgentN055032026-05-20
09350855000818CORIS Device EngineN055162026-05-20
09350855000832CORIS Adaptor O1N055172026-05-20
09350855000849CORIS Smart Drain Adaptor OAN055212026-05-20
09350855000856CORIS Smart DrainN055202026-05-20
09350855000863CORIS Maintenance KitN055222026-05-20
09350855000887CORIS Flushing AccessoryN055282026-05-20
09350855000894CORIS Smart Seal AN055232026-05-20
09350855000900CORIS Smart Seal BN055242026-05-20
09350855000993CORIS Device BodyN055152026-05-20
09350855001037trophon2 RefurbishedN05000-1R2025-11-01
09350855000740trophon3N05035-US2025-08-14
09350855000146trophon Sonex-HLN05002N05002-12PK2018-06-15
09350855000542trophon Chemical IndicatorN05003N050032022-05-12
09350855000047Trophon Chemical IndicatorN000912016-09-21
09350855000054Trophon Chemical IndicatorN00091-NNA2016-09-21
09350855000177trophon Chemical IndicatorN050032018-06-15
09350855000573trophon Wireless Ultrasound Probe HolderN05030-USN05030-US2024-10-25
09350855000009Trophon EPRN00010-US2016-09-21
09350855000016Trophon EPRN00010-NNA2016-09-21