FDA.reportPublic FDA data

LEONE SPA

Primary DI
08033707076896
Brand
LEONE SPA
Company
LEONE SPA
Model
X0031
Catalog number
X0031
Device description
DYNAMOMETER NEUTRAL
Published
2020-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJYPliers, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJYPliers, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033707076896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033707076896080337070768968033707076896

GMDN Terms#

Term, Definition table
TermDefinition
Hand dynamometer/pinchmeter, mechanicalA non-powered, mechanical instrument designed to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It is used to assess a patient's grip and/or pinch strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke. This device is commonly known as a Vigorimeter. It typically consists of various size squeeze bulbs and an analogue manometer to record the exerted effort. The patient will typically be asked to perform the test a few times so that the physician can obtain a mean value.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
432167294
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033707104513LEONE SPAA5133-97A5133-972026-05-28
08033707104827LEONE SPAA5134-02A5134-022026-04-01
08033707104834LEONE SPAA5134-03A5134-032026-04-01
08033707104469LEONE SPAR7200-08R7200-082025-09-11
08033707104476LEONE SPAA5132-07A5132-072025-09-11
08033707104483LEONE SPAA5132-17A5132-172025-09-11
08033707104490LEONE SPAA5132-95A5132-952025-09-11
08033707104506LEONE SPAA5132-97A5132-972025-09-11
08033707104391LEONE SPAA0620D911A0620D9112025-06-19
08033707104407LEONE SPAA0620D913A0620D9132025-06-19
08033707104414LEONE SPAA1621-911DA1621-911D2025-06-19
08033707104421LEONE SPAA1621-913DA1621-913D2025-06-19
08033707104438LEONE SPAA0631D908A0631D9082025-06-19
08033707104445LEONE SPAA0631D910A0631D9102025-06-19
08033707104452LEONE SPAA0631D912A0631D9122025-06-19
08033707094944LEONE SPAA0620D08A0620D082020-05-08
08033707094951LEONE SPAA0620D09A0620D092020-05-08
08033707094968LEONE SPAA0620D11A0620D112020-05-08
08033707094975LEONE SPAA0620D13A0620D132020-05-08
08033707103165LEONE SPAA0631D08A0631D082025-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB2140TBS BASICSACME ENTERPRISE.EJY2026-05-16
G149TBSB3070TBS BASICSACME ENTERPRISE.EJY2026-05-16
G149TBSB3080TBS BASICSACME ENTERPRISE.EJY2026-05-16
G149TBSB3090TBS BASICSACME ENTERPRISE.EJY2026-05-16
07898588840032PEAK 003ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840049PEAK 004ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840841121ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840902ELASTIC SETTERZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841244REPLACEMENTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841497TRIDENT CURTO MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841541TWEED OMEGA LOOP MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841602V BEND MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841657WEINGART MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841855117 PZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588842272117 IZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840223CONVENTIONAL LARGE LINGUALZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588840919CONVENTIONAL LINGUALZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588840964YARN SHORTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588841831CONVENTIONAL LINGUAL IOMZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588841954CUT SHORTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588843484YARN SHORTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588843521BILLER CHALLENGEZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25
07898588840070ABELL FOR PEDIATRIC DENTISTRYZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840155ANDREZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840858PARROT BEAKZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840872FLAT BEAKZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588840889BILLER CHALLENGEZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588841756MODIFIED ANDREZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588841763301 AIG 301ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24
07898588841770AIG 401ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-24