FDA.reportPublic FDA data

NA

Primary DI
07611819137233
Brand
NA
Company
Synthes GmbH
Model
530.783
Catalog number
530783
Device description
MODIFIED TRINKLE REAMING ATTACHMENT F/BATTERY POWER LN
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819137233Direct MarkingGS10
10886982240231PrimaryGS10
H6795307830SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819137233076118191372337611819137233
1088698224023110886982240231

GMDN Terms#

Term, Definition table
TermDefinition
Burring power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982350435NASD03.100.130SD031001302026-02-11
10886982350442NASD03.100.131SD031001312026-02-11
10886982350459NASD03.100.132SD031001322026-02-11
10886982350466NASD03.100.133SD031001332026-02-11
10886982351579NASD399.190SD3991902026-02-11
10886982351661NASD03.010.001SD030100012026-02-11
10886982351678NASD03.010.002SD030100022026-02-11
10886982361288NASD03.405.001SD034050012026-02-11
10886982361295NASD03.100.038SD031000382026-02-11
10887587078502NASD03.501.443SD035014432026-02-11
10887587078571NASD386.902SD3869022026-02-11
10886982351586NASD03.045.001SD030450012026-02-10
10886982351593NASD03.045.003SD030450032026-02-10
10886982362186NASD03.233.016SD032330162026-01-10
10886982362193NASD03.233.017SD032330172026-01-10
10886982362209NASD03.233.018SD032330182026-01-10
10886982362216NASD03.233.019SD032330192026-01-10
10886982361257VOLT60.529.210605292102025-12-16
H9810460002902S0NA04.600.029.02S0460002902S2019-08-20
H9810460002910S0NA04.600.029.10S0460002910S2019-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471220195De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-24
00889024706538REDUCED ZIMMER ANT ADAPTERZimmer, Inc.GEY2026-03-19
07613327656763BPXSTRYKER CORPORATIONGEY2026-03-04
07613327656770BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657760BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657777BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657784BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657791BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657814BPXSTRYKER CORPORATIONGEY2026-03-04
07613327659429BPXSTRYKER CORPORATIONGEY2026-03-04
05051471220812De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-02
05051471220836De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-02
05051471220263De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-01-29
00193982678906VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678913VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678920VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678982VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679002VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679286VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
05051471219625De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-01-05
04055207036693POWER STICK M5/0Richard Wolf GmbHGEY2025-12-18
05051471215283De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219038De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219175De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219199De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471214453De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214460De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214477De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214484De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214491De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17