FDA.reportPublic FDA data

NA

Primary DI
07611819719873
Brand
NA
Company
Synthes GmbH
Model
391.905.99
Catalog number
39190599
Device description
CABLE CUTTER-STANDARD
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
HTZINSTRUMENT, CUTTING, ORTHOPEDIC
HXZCUTTER, WIRE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819719873Direct MarkingGS10
10705034777276PrimaryGS10
10886982198396PrimaryGS10
H6793919050SecondaryHIBCC0
H981391905990SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819719873076118197198737611819719873
1070503477727610705034777276
1088698219839610886982198396

GMDN Terms#

Term, Definition table
TermDefinition
Wire cutterA heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. 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
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18
07649988948701SPIRECUTSPIRECUT SAHTZ2026-05-04
07649988948718SPIRECUTSPIRECUT SAHTZ2026-05-04
08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09
07898506814107QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506814114QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841677QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841691QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841707QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841714QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506841752QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506848959QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506849413QuinelatoSchobell Industrial LtdaHTZ2023-01-10
07898506849420QuinelatoSchobell Industrial LtdaHTZ2023-01-10
EZPF31760210HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHXZ2022-12-16
EZPF31760310HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHXZ2022-12-16
EZPF31760400HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHXZ2022-12-16
07898506814329QuinelatoSchobell Industrial LtdaHTZ2022-12-16
07898506838943QuinelatoSchobell Industrial LtdaHTZ2022-12-16
07898506841684QuinelatoSchobell Industrial LtdaHTZ2022-12-16
07898506842148QuinelatoSchobell Industrial LtdaHTZ2022-12-16
07898506848072QuinelatoSchobell Industrial LtdaHTZ2022-12-16
07898506853656QuinelatoSchobell Industrial LtdaHXZ2022-12-16
07898506853687QuinelatoSchobell Industrial LtdaHXZ2022-12-16
07898506853694QuinelatoSchobell Industrial LtdaHXZ2022-12-16
10840199517852Wire/Pin CutterKOROS U.S.A., INC.HXZ2021-10-01
10649111452567SklarSKLAR CORPORATIONHTZ2019-08-13
10649111452574SklarSKLAR CORPORATIONHTZ2019-08-13
10649111103346Sklar®SKLAR CORPORATIONHTZ2019-01-09
10649111441950Sklar®SKLAR CORPORATIONHTZ2019-01-09