FDA.reportPublic FDA data

DUOLITH®

Primary DI
07630039101398
Brand
DUOLITH®
Company
Storz Medical AG
Model
SD1 T-Top
Catalog number
21362.0102
Device description
The device is indicated for extracorporeal shock wave treatment.
Published
2021-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
NBNGenerator, Shock-Wave, For Pain Relief
PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBNGenerator, Shock-Wave, For Pain ReliefUnknown3
PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot UlcersGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202112000
P080028001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202112000Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpieceStorz Medical AG2021-02-21PZL
P080028001STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPYStorz Medical AG2016-01-08NBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630039101398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630039101398076300391013987630039101398

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy systemAn assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) and pneumatic pressure wave therapy to treat musculoskeletal disorders. It is typically mobile and includes a control unit that uses both an electrical current and compressed air to create kinetic energy which is transferred to a patient's body upon contact (e.g., with two different hand-held surface applicators) to produce mechanical shock waves at selected amplitudes and frequencies. It is used to treat soft-tissue pain and inflammation near bones, disorders such as tendinopathies and lateral/medial epicondylitis, and to stimulate osteogenesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481967776
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630039101855MASTERPULS®icon37000.00022026-04-15
07630039101909MASTERPULS®R-SW10043000.00022026-03-01
07630039100919MODULITH®SLX-F2290002021-04-13
07630039101817MASTERPULS®MP10023232.01042024-10-01
07630039101343DUOLITH®SD1 R-SW19880.00062021-06-01
07630039101169MASTERPULS®ONE2019-09-16
07630039101039D-ACTOR®2002018-05-28
07630039101060D-ACTOR®1002018-10-28
07630039101121D-ACTOR®502018-11-15
07630039101442MODULITH®SLX-F239000.00012025-04-11
07630039101459MODULITH®SLX-F239000.00022025-04-11
07630039101466MODULITH®SLX-F239000.00032025-04-11
07630039100803StorM-Base 2.032016-09-23
07630039100773DUOLITH®SD1 T-Top2016-06-27
07630039101336DUOLITH®SD1 Tower2020-03-23
07630039100230MODULITH®SLX-F22016-08-24
07630039101404DUOLITH®SD1 Tower19880.00052021-06-29
07630039101350MAGNETOLITH31500.00022021-06-01
07630039101329DUOLITH®SD1 T-Top2020-03-23
07630039101046XR-MX/1000FD43 (80 kW)292552021-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014430503CS-Pro MEDCURATIVE SOUND, LLCPZL2026-01-02
04260484571267Softwave Gold LiMTS Medical AGPZL2024-08-30
04260484571274Softwave Gold LiMTS Medical AGPZL2024-08-30
04260484571823Dermagold100MTS Medical AGPZL2023-09-11
04260484571830Dermagold100MTS Medical UG (haftungsbeschränkt)PZL2023-09-11
07630039101404DUOLITH®Storz Medical AGNBN2021-06-29
07630039101404DUOLITH®Storz Medical AGPZL2021-06-29
04260153472031Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2021-06-02
00812265010201dermaPACE ApplicatorSANUWAVE Health, Inc.PZL2021-01-25
00812265010218dermaPACE ConsoleSANUWAVE Health, Inc.PZL2021-01-25
00812265010225dermaPACE System (Console with applicator)SANUWAVE Health, Inc.PZL2021-01-25
07613353194895SWISS DOLORCLASTE.M.S. Electro Medical Systems S.A.NBN2020-08-25
07613353170264Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2020-06-03
04260484571649DermaGold100®MTS Medical AGPZL2020-03-31
07630039101312CHATTANOOGAStorz Medical AGNBN2020-03-23
07630039101329DUOLITH®Storz Medical AGNBN2020-03-23
07630039101336DUOLITH®Storz Medical AGNBN2020-03-23
07613353181284Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2019-10-16
07613353077464Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2018-06-22
07630039101022CHATTANOOGAStorz Medical AGNBN2018-05-28
07290016498417OrthospecMEDISPEC LTD.NBN2017-06-22
07630039100827CHATTANOOGAStorz Medical AGNBN2017-01-16
07630039100759CHATTANOOGAStorz Medical AGNBN2016-06-27
07630039100773DUOLITH®Storz Medical AGNBN2016-06-27
07613353000011Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000028Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000042Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000059Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000066Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-11-04
07613353000035Swiss DolorClastE.M.S. Electro Medical Systems S.A.NBN2015-10-26