FDA.report

Shaver 10mm

Primary DI
09348215067243
Brand
Shaver 10mm
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
132-072-016
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09348215067243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09348215067243093482150672439348215067243

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
751993028
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 DIBrandModelCatalogPublished
09348215039295Liner Impactor112-152-0022018-10-09
09348215039301Liner Impactor112-152-3342018-10-09
09348215039318Liner Impactor112-152-1212018-10-09
09348215039325Liner Impactor112-152-0032018-10-09
09348215039332Ceramic Liner Inserter Impactor Head112-152-2102018-10-09
09348215039349Ceramic Liner Inserter Impactor Head112-152-2112018-10-09
09348215039356Ceramic Liner Inserter Impactor Head112-152-2122018-10-09
09348215039363Ceramic Liner Inserter Impactor Head112-152-2132018-10-09
09348215039387Ceramic Liner Impact Adaptor112-152-3052018-10-09
09348215039615Quick Release Head Impactor112-212-0172018-10-09
09348215039837Quick Release Stem Impactor112-212-0062018-10-09
09348215040758Head Impactor112-28-00112018-10-09
09348215040796Stem Impactor112-28-00292018-10-09
09348215040826Monoblock Head Impactor112-28-00382018-10-09
09348215040888Mjolnir112-28-00602018-10-12
09348215041250Femoral Impactor122-15-04642018-10-09
09348215041779Tibial Impactor122-15-04622018-10-09
09348215137427Swivel Stem Impactor112-32-03132025-10-10
09348215137434Swivel Stem Impactor - Long112-32-0314 2025-10-10
09348215152673Proximal Reamer Ø12111-552-4222025-09-16

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