FDA.reportPublic FDA data

ROD CUTTER

Primary DI
G426SI10380
Brand
ROD CUTTER
Company
STONE INSTRUMENTS CO
Model
SI-1038
Device description
ROD CUTTER EXTRA LONG, CUT MULTIPLE RODS SIZES
Published
2023-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G426SI10380PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
645446428
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
G426TI02000Stone Instruments CoTI-0200TI-02002026-01-17
G426SI10410IN-SITU ROD BENDER SI-10412023-03-09
G426SI10460ROD BENDER SI-10462023-03-09
G426SI10500ROD FORK SI-10502023-03-09
G426STNKLTR0614240PLATE HOLDING FORCEPSKLTR0614242024-08-20
G426KLTR032223PF0PLATE HOLDING FORCEPSKLTR032223PF 2023-04-29
G426KLTR032223V010PLATE HOLDING FORCEPSKLTR032223V01 2023-04-29
G426SI10010SPREADER SI-10012023-03-09
G426SI10060COMPRESSOR SI-10062023-03-09
G426SI10230ROD HOLDER SI-10232023-03-09
G426SI1023CA0ROD HOLDER SI-1023-CA2023-03-09
G426SI10860EGG HANDLE RATCHET SI-10862023-03-09
G426SI11740T HANDLE RATCHETSI-11742023-03-09
G426KLTR030422L0STONE INSTRUMENTS CO KL-TR030422-L2023-02-22
G426KLTR030422M0STONE INSTRUMENTS CO KL-TR030422-M2023-02-21

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