FDA.reportPublic FDA data

NA

Primary DI
10886982198150
Brand
NA
Company
Synthes GmbH
Model
391.107
Catalog number
391107
Device description
LARGE CABLE PASSER
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819719774Direct MarkingGS10
10886982198150PrimaryGS10
H6793911070SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819719774076118197197747611819719774
1088698219815010886982198150

GMDN Terms#

Term, Definition table
TermDefinition
Wire twisterA surgical instrument specifically designed to twist surgical wire after this has been applied to the site in order to tighten the loop or binding that has been made by the surgeon. The loose ends of the wire are inserted into and gripped by the jaws of this device, and the surgeon pulls a handle which spins the spirally grooved centre piece, thereby twisting and tightening the wire. It is typically used in orthopaedic procedures. 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
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078396389TruTORQ Offset T-Handle Sterile, Single UseEca Medical InstrumentsLXH2026-10-20
10810128464144Tendon Stripper, ClosedT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464151Tendon Stripper, OpenT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
B504OMBMAS90006S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90007S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
B504OMST60071041500BrasselerProvisionLXH2026-10-20
B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16