FDA.reportPublic FDA data

OSTEOTOME

Primary DI
00888118117090
Brand
OSTEOTOME
Company
KLS-Martin L.P.
Model
37-626-18-07
Device description
STEINBACHER, W/2.5 MM GUIDE, 5 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
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118117090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118117090008881181170908881181170900888118117090

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.

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
00888118108357DISTRACTION, INTERNAL, STERILE51-556-20-812018-09-26
00888118108364DISTRACTION, INTERNAL, STERILE51-557-20-812018-09-26
00888118147226LEVEL ONE EXTREMITY26-950-64-042026-07-21
00888118147233LEVEL ONE EXTREMITY26-950-65-042026-07-21
00888118147240LEVEL ONE EXTREMITY26-950-66-042026-07-21
00888118147257LEVEL ONE EXTREMITY26-950-67-042026-07-21
00888118147264LEVEL ONE EXTREMITY26-950-68-042026-07-21
00888118147271LEVEL ONE EXTREMITY26-950-69-042026-07-21
00888118147714LEVEL ONE EXTREMITY26-950-58-042026-07-21
00888118147721LEVEL ONE EXTREMITY26-950-59-042026-07-21
00888118147738LEVEL ONE EXTREMITY26-950-62-042026-07-21
00888118147745LEVEL ONE EXTREMITY26-950-63-042026-07-21
00888118154620LEVEL ONE CMF25-315-92-912026-07-21
00888118154637LEVEL ONE CMF50-743-06-092026-07-21
00888118154644LEVEL ONE, STERILE25-433-97-712026-07-21
00888118154651LEVEL ONE, STERILE25-438-97-712026-07-21
00888118154668LEVEL ONE, STERILE25-439-91-712026-07-21
00888118154675LEVEL ONE, STERILE25-486-97-712026-07-21
00888118154682LEVEL ONE, STERILE25-487-97-712026-07-21
00888118154699LEVEL ONE, STERILE50-817-15-712026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431570MillenniumAvalign Technologies, Inc.HWM2026-09-22
00190776431037MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431044MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431051MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431020MillenniumAvalign Technologies, Inc.HWM2026-09-18
00190776429089MillenniumAvalign Technologies, Inc.HWM2026-09-04
00190776429096MillenniumAvalign Technologies, Inc.HWM2026-09-04
00810111227360OsteotomeTreace Medical Concepts, Inc.HWM2026-08-25
00190776425807MillenniumAvalign Technologies, Inc.HWM2026-08-17
10705034579887N/AMedos International SàrlHWM2026-08-14
10705034579894N/AMedos International SàrlHWM2026-08-14
00190776424459MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776424466MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776424473MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776422738MillenniumAvalign Technologies, Inc.HWM2026-08-03
07640221373663SCALASpineArt SAHWM2026-07-24
07640221373670SCALASpineArt SAHWM2026-07-24
00190776421861MillenniumAvalign Technologies, Inc.HWM2026-07-23
00190776400422MillenniumAvalign Technologies, Inc.HWM2026-07-17
00190776400439MillenniumAvalign Technologies, Inc.HWM2026-07-17
B756SBLDFLAT17010Shukla Blade S9BLADEShukla MedicalHWM2026-07-09
B756SBLDFLAT17020Shukla Blade S9BLADEShukla MedicalHWM2026-07-09
00810143904666SURGIPROSSurgipros, LLCHWM2026-06-01
00810143904673SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907261SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907278SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907308SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907315SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930008SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930015SURGIPROSSurgipros, LLCHWM2026-06-01