FDA.reportPublic FDA data

LEVER

Primary DI
00888118072368
Brand
LEVER
Company
KLS-Martin L.P.
Model
48-380-02-07
Device description
RETROMAXILLARY, TESSIER, LEFT, 9 MM TIP
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXPINSTRUMENT, BENDING OR CONTOURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118072368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118072368008881180723688881180723680888118072368

GMDN Terms#

Term, Definition table
TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569620479Newclip InstrumentsNEWCLIP TECHNICSHXP2026-05-07
00840311262960Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HXP2026-04-27
00199150066919Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2026-03-02
07640187463149Bending Iron SmallBonebridge AGHXP2026-01-16
07640187463156Bending Plier SmallBonebridge AGHXP2026-01-16
07640187463163Cutting PlierBonebridge AGHXP2026-01-16
00199150029464Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-10-19
M711CI1310Opteryx®INNO Holdings, Inc.HXP2025-06-30
08800071031833SignexOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697369Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697376Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809416068626Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-25
08403207010032Anmuth Medical InternationalAnmuth Medical International, LLCHXP2025-06-09
00763000987336Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-02-28
00841435124707TecometTECOMET INC.HXP2024-12-19
03700569652937Newclip InstrumentsNEWCLIP TECHNICSHXP2024-11-07
00763000837099CD Horizon™ ModuLeX™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HXP2024-10-27
10886982335784NASynthes GmbHHXP2024-10-09
10886982335913NASynthes GmbHHXP2024-10-09
10886982336293NASynthes GmbHHXP2024-10-09
10886982336309NASynthes GmbHHXP2024-10-09
07612334236012NASynthes GmbHHXP2024-10-09
07612334236173NASynthes GmbHHXP2024-10-09
07612334236630NASynthes GmbHHXP2024-10-09
07612334236647NASynthes GmbHHXP2024-10-09
00810112597943MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHXP2024-07-31
00810112597974MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHXP2024-07-31
04719878787055“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXP2024-04-15
00888233069762STERNALOCK EZBIOMET MICROFIXATION, INCHXP2024-03-25
00888515202146BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXP2024-02-28