FDA.reportPublic FDA data

NA

Primary DI
07611819348646
Brand
NA
Company
Synthes GmbH
Model
03.113.016
Catalog number
03113016
Device description
NUT F/PULL REDUCTION DEVICE
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
HTJGAUGE, DEPTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819348646Direct MarkingGS10
10886982072832PrimaryGS10
H679031130160SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819348646076118193486467611819348646
1088698207283210886982072832

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone nutA sterile profiled block made of metallic or non-metallic material that is threaded on its inside surface, and designed to securely fasten a bone fixation bolt, possibly with a washer. This is a single-use 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
00199150076192Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTJ2026-05-23
08809945895076EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-03-23
00810111225649Depth GageTreace Medical Concepts, Inc.HTJ2026-03-19
10885862661449N/AExactech, Inc.HTJ2026-03-19
00840124525450Depth GaugeFUSION ORTHOPEDICS, LLCHTJ2026-03-06
08809945895021EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895038EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895045EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895052EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895069EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895083EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895090EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895106EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895113EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
00810112597486TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2026-02-10
06438394001534Activa InstrumentBioretec OyHTJ2026-01-30
06438394001541Activa InstrumentBioretec OyHTJ2026-01-30
06438394005266Activa InstrumentBioretec OyHTJ2026-01-28
00840124525191DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00840124525207DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00840124525214DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00841731135520Redemption VILEX LLCHTJ2026-01-13
00841506137520ProteanSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506138077ProteanSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506138947Proximal Humerus Plating SystemSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506145945Proximal Humerus Plating SystemSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
04262494462580N/ADoppkon GmbH & Co. KGHTJ2025-12-01
08056693027987INTRAUMA SURGICAL INSTRUMENTINTRAUMA SPAHTJ2025-11-27
08800068959690LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25
08800068959706LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25