FDA.reportPublic FDA data

NA

Primary DI
07611819075795
Brand
NA
Company
Synthes GmbH
Model
356.340
Catalog number
356340
Device description
DRIVE SHAFT 490MM
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
HWBEXTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819075795Direct MarkingGS10
10886982195449PrimaryGS10
H6793563400SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819075795076118190757957611819075795
1088698219544910886982195449

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, reusableA long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862648143EquinoxeExactech, Inc.HWB2026-03-19
10885862660466N/AExactech, Inc.HWB2026-03-19
10885862663214N/AExactech, Inc.HWB2026-03-19
B922F00500380ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWB2026-03-11
00841435122574TecometTECOMET INC.HWB2026-02-27
07899258695174Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695181Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695198Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695204Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695211Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695228Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695235Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
03662663131759Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWB2026-02-11
00840338602497Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338602961Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338607799Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00840338607805Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00889024704008LB Type 1 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704015LZ 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704022LB 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704039Fitmore Extraction Adapter - MZimmer, Inc.HWB2025-12-18
00889024704046Fitmore Extraction Adapter - FZimmer, Inc.HWB2025-12-18
03662663274128Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-18
03662663217415Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217439Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217446Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217453Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217460Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663279277Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-16
10603295505044ATTUNEDEPUY (IRELAND)HWB2025-12-11