FDA.reportPublic FDA data

Sonata® IUUS Probe Connector Protector

Primary DI
10817929020463
Brand
Sonata® IUUS Probe Connector Protector
Company
Gynesonics, Inc.
Model
ACCY-018
Catalog number
ACCY-018
Device description
Accessory to the Sonata® Intrauterine Ultrasound (IUUS) Probe. Provides water-tight cover for the electrical connector of the IUUS Probe during liquid reprocessing procedures.
Published
2022-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222304000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222304000Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.2022-11-08KNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817929020463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081792902046310817929020463

GMDN Terms#

Term, Definition table
TermDefinition
Non-submersible device disinfection chamberA vessel designed to protect the part of a device that cannot be exposed to liquid cleaning agents or disinfectant [e.g., the electrical connector of a transoesophageal echocardiography (TOE) probe] in a water-tight vault that may be air-pressurized, so the patient-contact part of the device can be nonthermally, chemically decontaminated and/or high-level disinfected (e.g., in an automated endoscope washer/disinfector). It is typically made of metals and polymers [e.g., stainless steel, silicone, and polycarbonate (PC)] and consists of a housing with a clamp, seal, cap, and/or valves. It is typically used in instrument and endoscopy cleaning rooms. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-216-3860UScustomerservice@gynesonics.com

Regulatory Flags#

DUNS number
618493741
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817929020241Sonata® Intrauterine Ultrasound ProbeIUSP-002SIUSP-002S2019-05-10
10817929020364Sonata® Dispersive ElectrodeDE-001DE-0012021-07-07
30817929020177Sonata® RFA Handpiece Cable, ReusableACCY-008ACCY-0082021-07-07
30817929020450Sonata® IUUS Probe Leak TesterACCY-017ACCY-0172023-06-20
10817929020449Sonata® IUUS probe Leak Tester KitACCY-016ACCY-0162023-06-20
10817929020371Sonata® Radiofrequency Ablation HandpieceRFA-002RFA-0022021-07-07
10817929020357Sonata® System SoftwareSW-001SW-0012020-02-21
10817929020036Sonata® Intrauterine Ultrasound Probe Return KitRTN-001RTN-0012020-10-07
10817929020166Sonata® Procedure Kit PROKIT-001PROKIT-0012020-10-07
10817929020340Sonata System SoftwareSW-002SW-0022020-10-07
10817929020005Sonata® Case Kit CSKIT-001CSKIT-0012019-05-10
10817929020135Sonata® IUUS Probe Sterile Shipper KitSHPR-001SHPR-0012019-05-10
10817929020142Sonata® IUUS Probe Soaking CylinderCYL-001CYL-0012019-05-10
10817929020180Sonata® System Cart ACCY-002ACCY-0022019-05-10
10817929020197Sonata® SMART TabletUSCON-2200USCON-22002019-05-10
10817929020203Sonata® System Radiofrequency GeneratorRFG2-110RFG2-1102019-05-10
10817929020326Sonata® Sonography-Guided Transcervical Fibroid Ablation System SONATA2-110SONATA2-1102019-05-10
30817929020092Sonata® Intrauterine Ultrasound ProbeIUSP-002IUSP-0022019-05-10
10817929020456Sonata® IUUS Probe Leak TesterACCY-017ACCY-0172023-06-20
30817929020368Sonata® Dispersive ElectrodeDE-001DE-0012021-07-07

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