FDA.reportPublic FDA data

SONOCA 300

Primary DI
04250321532667
Brand
SONOCA 300
Company
Söring GmbH
Model
15-000B-FL
Device description
Ultrasonic generator, 115V
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992026000SORING GMBH, SONOCA 300Soring GmbH Medizintechnik1999-09-23BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250321532667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250321532667042503215326674250321532667

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic surgical system generatorAn electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.

Sterilization Methods#

Method table
Method

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250321528325NA700S03162016-09-17
04250321519965UAW Instrument97-10297-1022023-06-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014862731HEYVALUEOak Tech LLCBTA2026-03-27
00860014862748GROWNSYOak Tech LLCBTA2026-03-27
10845854041413APEXConmed CorporationBTA2026-03-23
10845854080153CONMEDConmed CorporationBTA2026-03-23
00810149098246R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-02-12
00810149098222R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-01-20
00860014862700GROWNSYOak Tech LLCBTA2026-01-10
00860014862717GROWNSYOak Tech LLCBTA2026-01-10
00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
00860014577567HEYVALUEOak Tech LLCBTA2025-10-13
00860014577574HEYVALUEOak Tech LLCBTA2025-10-13
00860014577581HEYVALUEOak Tech LLCBTA2025-10-13
00860014577505GROWNSYOak Tech LLCBTA2025-08-26
00860014577512GROWNSYOak Tech LLCBTA2025-08-26
00860014577529GROWNSYOak Tech LLCBTA2025-08-26
06953775661706BBLOVEAlicn Medical Shenzhen, Inc.BTA2025-08-04
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit FussschalterArdo medical AGBTA2025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115VArdo medical AGBTA2025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115VArdo medical AGBTA2025-07-16
00810149097997R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-23
00810149097973R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
00810149097980R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
06975740361558MomcozyShenzhen Root Innovation Technology Co., Ltd.BTA2025-05-20
06978331170218BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170232BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170249BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170256BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31