FDA.report

NA

Primary DI
07611819087415
Brand
NA
Company
Synthes GmbH
Model
511.902
Catalog number
511902
Device description
RECIPROCATING SAW ATTACHMENT
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

Related Records

Contact Domains

Product Codes

CodeName
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07611819087415Direct MarkingGS10
10886982238078PrimaryGS10
H6795119020SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07611819087415076118190874157611819087415
1088698223807810886982238078

GMDN Terms

TermDefinition
Sawing power tool attachment, reciprocatingA 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 reciprocating sawing function when a reciprocating saw blade is inserted. This attachment is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. It is typically of the macro design. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
08404535025156LARGE BONE BLADESPeter Brasseler Holdings, LLCGFA2026-03-23
B504OM4515700130DePuy MitekProvisionGFA2026-03-19
B504OM50715940Conmed LinvatecProvisionGFA2026-03-19
B504OMDC119090180Conmed LinvatecProvisionGFA2026-03-19
00810111225366Saw BladeTreace Medical Concepts, Inc.GFA2026-01-26
00810111225342Saw BladeTreace Medical Concepts, Inc.GFA2026-01-07
00810111225335Saw BladeTreace Medical Concepts, Inc.GFA2025-12-18
08681506801180SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIGFA2025-12-12
B39062901120331Reprocessed 3mm Straight Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040121Reprocessed 4mm Angled 12 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040601Reprocessed 4mm Angled 60 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
16974940305963endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305970endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305987endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305994endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306007endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306014endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306021endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306038endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
06974940306048endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
06974940306055endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306069endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306076endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306083endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306090endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306106endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306113endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306120endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306137endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
00887919258568Large Bone BladePeter Brasseler Holdings, LLCGFA2025-11-26