FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704286052
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015164
Catalog number
KM55333
Device description
RHOTON ELEVATOR CURVED 7.5"
Published
2018-09-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704286058Direct MarkingGS10
24026704286052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704286058040267042860584026704286058
2402670428605224026704286052

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19.1Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
true
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898789390015TREPSAT FACELIFT DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-23
00192896122888DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122895Ball DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122901Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122918Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122925Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122932Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
09348811151254INKAThe Trustee for KAISER FAMILY TRUSTGDI2026-03-16
00192896122703Ochsner DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-10
00840180544778General InstrumentsALPHATEC SPINE, INC.GDI2026-01-29
00840180544525General InstrumentsALPHATEC SPINE, INC.GDI2025-12-31
08809407604543DissectorHankil Tech Medical Co., Ltd.GDI2025-12-16
00196449034536Anatomic Access LLIFTyber Medical, LLCGDI2025-12-02
09348811025494INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811025500INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811146663INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
03662663276849Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-17
00757770701209Bausch + LombBausch & Lomb IncorporatedGDI2025-11-16
03662663267236Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267243Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267250Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
00757770676354Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
00757770688517Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
03662663131308Disc Preparation InstrumentsHighridge Medical, LLCGDI2025-11-14
03662663192835Breckenridge ACDF SystemHighridge Medical, LLCGDI2025-11-14
00196449034529Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00763000936440NAMEDTRONIC, INC.GDI2025-09-29
00192896122116Ball ProbeSONTEC INSTRUMENTS, INC.GDI2025-09-26
16971503601937comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
16971503601944comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28