FDA.reportPublic FDA data

NA

Primary DI
10886982198105
Brand
NA
Company
Synthes GmbH
Model
391.10
Catalog number
39110
Device description
45MM WIRE PASSER STANDARD 220MM
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXIPASSER, WIRE, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982198105PrimaryGS10
H679391100SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698219810510886982198105

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

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Primary DI, Brand, Company table
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00841731138095TITANEX VILEX LLCHXI2026-05-15
00841731142870TITANEX VILEX LLCHXI2026-05-15
00841731142887TITANEX VILEX LLCHXI2026-05-15
00841731146717TITANEXVILEX LLCHXI2026-05-15
00841731146724TITANEXVILEX LLCHXI2026-05-15
00841731146731TITANEXVILEX LLCHXI2026-05-15
00841731147141TITANEX VILEX LLCHXI2026-05-15
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00889795152695Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
B8034803860ORTHOMEDORTHO-MED, INC.HXI2026-04-16
B8034803880ORTHOMEDORTHO-MED, INC.HXI2026-04-16
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00841731134769Hintermann Series VILEX LLCHXI2026-01-16
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