FDA.reportPublic FDA data

UAW Instrument

Primary DI
04250321519965
Brand
UAW Instrument
Company
Söring GmbH
Model
97-102
Catalog number
97-102
Device description
UAW instrument, double-ball, 61mm, Ø5mm
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFLInstrument, Ultrasonic Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFLInstrument, Ultrasonic SurgicalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072904000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072904000SONOCA 180/195 WOUND CARE SYSTEMSoering GmbH2008-05-21LFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250321519965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250321519965042503215199654250321519965

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical system handpiece, reusableA hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end to mechanically fragment soft-tissue cells upon contact for cutting and/or coagulating tissue during surgery. The handpiece may also serve as a conduit for irrigation and aspiration during surgery. It is typically in the form of a pen/pencil or elongated probe with permanently attached cables. This is a non-dedicated device intended to be used in multiple clinical specialties. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
844 476 7464UDI-inquiry@soering.com

Regulatory Flags#

DUNS number
322238346
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250321528325NA700S03162016-09-17
04250321519989UAW Instrument97-10497-1042023-06-12
04250321520008UAW Instrument97-11297-1122023-06-12
04250321523535UAW Instrument97-10397-1032023-06-12
04250321532612SONOCA 185S185-000B-FLS185-000B-FL2023-06-12
04250321519217ENP92-0302016-09-17
04250321527588NA770S00012016-09-17
04250321532315ARCO 300068-000B-FL2016-09-17
04250321532346BCC 140B140-0000B-FL2016-09-17
04250321532483MBC 200M200-0000B-FL2016-09-17
04250321532575MBC 601 UAM88-000B-UAM-FL2016-09-17
04250321522897NA300K00112016-09-17
04250321522903NA300K00132016-09-17
04250321512591NA612K0037-502016-09-17
04250321512652NA612K0039-502016-09-17
04250321519125Pen91-0212016-09-17
04250321519637LUD94-0542016-09-17
04250321519699NA94-106-HF2016-09-17
04250321523245NA612K0038-502016-09-17
04250321523511Pen91-0202016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327586565N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
07613327586589N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
10705036035763HarmonicETHICON ENDO-SURGERY, LLCLFL2024-03-01
10705036035770HarmonicETHICON ENDO-SURGERY, LLCLFL2024-03-01
10705036035787HarmonicETHICON ENDO-SURGERY, LLCLFL2024-03-01
10381780536383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-07-14
10381780533870CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
10381780533894CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
07613327576627Sonopet iQSTRYKER CORPORATIONLFL2023-03-24
10381780536369CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780536352CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780533863CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-09-06
07613327548105Sonopet iQSTRYKER CORPORATIONLFL2021-06-14
10705036026167HarmonicETHICON ENDO-SURGERY, LLCLFL2020-12-18
10705036026174HarmonicETHICON ENDO-SURGERY, LLCLFL2020-12-11
10857156006076Tenex Health TX®TENEX HEALTH, INC.LFL2020-07-15
10857156006144Tenex Health TX®TENEX HEALTH, INC.LFL2020-07-15
10857156006205Tenex Health TX®TENEX HEALTH, INC.LFL2020-07-15
07613327298635Sonopet iQSTRYKER CORPORATIONLFL2019-05-10
10381780466215CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
10381780466383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
07613327422382Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422399Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422405Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422412Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422429Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422436Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422443Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422450Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422467Sonopet iQSTRYKER CORPORATIONLFL2019-05-02