FDA.reportPublic FDA data

OBWEGESER RAMUS OSTEOTOME

Primary DI
00192896042742
Brand
OBWEGESER RAMUS OSTEOTOME
Company
SONTEC INSTRUMENTS, INC.
Model
475-749
Catalog number
475-749
Device description
OBWEGESER RAMUS OSTEOTOME CURVED SHAFT
Published
2018-09-14
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
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896042742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896042742001928960427421928960427420192896042742

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.25Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896015104REEH STITCH SCISSORS13-832513-83252018-09-12
00192896062238RYDER NEEDLE HOLDER2300-3152300-3152018-09-12
00192896105171Small Plates355-236A355-236A2020-10-05
00192896122833Intraocular Set1100-034-SET1100-034-SET2026-03-19
00192896122840Alyea-Babcock Vasectomy Clamp516-695516-6952026-03-19
00192896122857Diamond Head Grasping Forceps1273-1251273-1252026-03-19
00192896122864Velociraptor Junior Rongeur1273-171F1273-171F2026-03-19
00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
00192896122949Deluxe Alligator Grasping Forceps1100-333D1100-333D2026-03-19
00192896122680Schroeder Vulsellum Bone Clamp1103-0641103-0642026-03-10
00192896122697Cooley Vascular Clamp2100-527C2100-527C2026-03-10
00192896122703Ochsner Dissector2700-155T2700-155T2026-03-10
00192896122710Debakey Coarctation Clamp2100-6312100-6312026-03-10
00192896122727Debakey Coarctation Clamp2100-6352100-6352026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800270Adler Instrument CompanyAdler, Inc.HWM2026-05-26
00810220800287Adler Instrument CompanyAdler, Inc.HWM2026-05-26
10885862663238N/AExactech, Inc.HWM2026-03-19
00190776417796MillenniumAvalign Technologies, Inc.HWM2026-03-11
00190776417802MillenniumAvalign Technologies, Inc.HWM2026-03-11
M9307867516310Life InstrumentsLife Instrument CorporationHWM2026-03-06
00840319758861Hayden MedicalHayden Medical, Inc.HWM2026-03-05
00840319758878Hayden MedicalHayden Medical, Inc.HWM2026-03-05
00190776417611MillenniumAvalign Technologies, Inc.HWM2026-03-04
04046826118327MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWM2026-02-27
04046826118341MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWM2026-02-27
03662663109598Mergence-A Preparation InstrumentationHighridge Medical, LLCHWM2026-02-11
03662663131780Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWM2026-02-11
10886982361295NASynthes GmbHHWM2026-02-11
00840277133243Innomed, Inc.INNOMED, INC.HWM2026-02-06
00840277133250Innomed, Inc.INNOMED, INC.HWM2026-02-06
03662663084079ActivLHighridge Medical, LLCHWM2026-02-03
00190776415464MillenniumAvalign Technologies, Inc.HWM2026-01-27
03662663155786Zyston Interbody Spacer SystemHighridge Medical, LLCHWM2025-12-29
03662663155809Zyston Interbody Spacer SystemHighridge Medical, LLCHWM2025-12-29
03662663216005Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216012Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216241Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216258Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216265Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216319Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216326Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216333Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216340Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216357Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17