FDA.reportPublic FDA data

OrthoMedFlex

Primary DI
M7161011240
Brand
OrthoMedFlex
Company
ORTHOMEDFLEX LLC
Model
101-124
Catalog number
101-124
Device description
Quick Release Box Osteotome
Published
2016-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M7161011240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotome blade, reusableA sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on one or both sides; it is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8446633539info@orthomedflex.com

Regulatory Flags#

DUNS number
034442726
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
M7161011020OrthoMedFlex101-1021011022016-08-30
M7161011250OrthoMedFlex101-125101-1252016-08-29
M7161011260OrthoMedFlex101-126101-1262016-08-29
M7161011340OrthoMedFlex101-134101-1342016-08-30
M7161011430OrthoMedFlex, LLC101-143101-1432017-09-19
M716101164280OrthoMedFlex101-164-28101-164-282016-08-29
M716101164360OrthoMedFlex101-164-36101-164-362016-08-29
M7161011710OrthoMedFlex101-171101-1712016-08-29
M7161012260OrthoMedFlex101-226101-2262016-09-01
M7161012290OrthoMedFlex101229101-2292017-03-07
M7161012400OrthoMedFlex101240101-2402017-10-03
M7161012430OrthoMedFlex101-243101-2432021-06-24
M7161013010OrthoMedFlex101-301101-3012016-08-31
M7161013020OrthoMedFlex101-302101-3022016-08-31
M7161013040OrthoMedFlex, LLC101-304101-3042017-04-25
M7161013190OrthoMedFlex101-319101-3192016-08-29
M7161013190210OrthoMedFlex101319021101-319-0212017-02-23
M7161013310OrthoMedFlex, LLC101-331101-3312017-09-19
M7161013510OrthoMedFlex101-351101-3512016-08-31
M7161013520OrthoMedFlex, LLC101-352101-3522017-04-21

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