FDA.reportPublic FDA data

NA

Primary DI
H981SD3881400
Brand
NA
Company
Synthes GmbH
Model
SD388.140
Catalog number
SD388140
Device description
6MM SOCKET WRENCH WITH QC
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
HXCWRENCH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034706467PrimaryGS10
H981SD3881400SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503470646710705034706467

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. 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
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000837181Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.HXC2026-07-17
18257200066810PROVIEWOrthofix US LLCHXC2026-07-17
B756007053001000Torque WrenchShukla MedicalHXC2026-06-01
10886982362964NASynthes GmbHHXC2026-05-04
08059386742273Orthopaedic Surgical InstrumentsCITIEFFE SRLHXC2025-11-05
1085007050056915mm CurvaFix Hex Wrench CURVAFIX, INC.HXC2025-10-22
10889981437794SpecialsSeaspine Orthopedics CorporationHXC2025-10-17
18059015376494ORTHOFIXORTHOFIX SRLHXC2025-03-31
08800104097966Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXC2025-03-17
08809885799762Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXC2025-03-17
08809885799816AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.HXC2025-03-17
18059015376029TRUELOK SYSTEMORTHOFIX SRLHXC2025-01-10
10840199540805Modified Kaufman Type Kidney ClampKOROS U.S.A., INC.HXC2024-01-31
00841732144309GENERIC Surgical InstrumentsCTL Medical CorporationHXC2023-09-15
08800068966230LOSPA Modular Knee SystemCorentec Co., LtdHXC2022-10-24
08800068964960LOSPA Modular Knee System Corentec Co., LtdHXC2022-10-23
10845854023976ULTRAPOWERConmed CorporationHXC2022-06-02
B07301K0360280Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380000Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380010Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380020Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380030Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380220Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380240Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380260Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380300Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380420Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
10886982195722NASynthes GmbHHXC2019-02-21
08809265159063Surgical InstrumentJeil Medical CorporationHXC2018-11-28