FDA.reportPublic FDA data

Sonata® IUUS Probe Sterile Shipper Kit

Primary DI
10817929020135
Brand
Sonata® IUUS Probe Sterile Shipper Kit
Company
Gynesonics, Inc.
Model
SHPR-001
Catalog number
SHPR-001
Device description
Sterilization packaging, single use
Published
2019-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173703000Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.2018-08-15KNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817929020135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081792902013510817929020135

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius29 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817929020357Sonata® System SoftwareSW-001SW-0012020-02-21
10817929020340Sonata System SoftwareSW-002SW-0022020-10-07
30817929020474Sonata Dispersive ElectrodeDE-0022026-08-25
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
10817929020463Sonata® IUUS Probe Connector Protector ACCY-018ACCY-0182022-12-12
10817929020449Sonata® IUUS probe Leak Tester KitACCY-016ACCY-0162023-06-20
10817929020371Sonata® Radiofrequency Ablation HandpieceRFA-002RFA-0022021-07-07
10817929020036Sonata® Intrauterine Ultrasound Probe Return KitRTN-001RTN-0012020-10-07
10817929020166Sonata® Procedure Kit PROKIT-001PROKIT-0012020-10-07
10817929020005Sonata® Case Kit CSKIT-001CSKIT-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

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Primary DI, Brand, Company table
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