FDA.reportPublic FDA data

LONESTAR

Primary DI
18257200026009
Brand
LONESTAR
Company
ORTHOFIX INC.
Model
83-8842
Device description
17mm W x 13mm L x 12mm H, 7° LORDOTIC RASP
Published
2017-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200026009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720002600918257200026009

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Height12Millimeter
Length13Millimeter
Width17Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)937-3199osi-customerservice@orthofix.c

Regulatory Flags#

DUNS number
927083808
Device count
1
DM exempt
true
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
true
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
18257200126712FIREBIRD SFS44-33102019-03-12
18257200126729FIREBIRD SFS44-33112019-03-12
18257200126736FIREBIRD SFS44-33252019-03-12
18257200126743FIREBIRD SFS44-33302019-03-12
18257200126750FIREBIRD SFS44-33352019-03-12
18257200126767FIREBIRD SFS44-33402019-03-12
18257200126774FIREBIRD SFS44-33452019-03-12
18257200126781FIREBIRD SFS44-33502019-03-12
18257200126798FIREBIRD SFS44-33552019-03-12
18257200126804FIREBIRD SFS44-33602019-03-12
18257200126811FIREBIRD SFS44-33652019-03-12
18257200126828FIREBIRD SFS44-33702019-03-12
18257200126835FIREBIRD SFS44-33752019-03-12
18257200126842FIREBIRD SFS44-33802019-03-12
18257200126859FIREBIRD SFS44-33852019-03-12
18257200127900FIREBIRD SFS77-74102019-03-12
18257200127917FIREBIRD SFS77-74112019-03-12
18257200127924FIREBIRD SFS77-74202019-03-12
18257200127931FIREBIRD SFS77-74252019-03-12
18257200127948FIREBIRD SFS77-74302019-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08806395408924PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408931PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408948PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408955PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408962PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408979PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408986PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408993PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395409006PulsarGS Medical Co., Ltd.HTR2022-11-01
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