FDA.report

ORTHOMED

Primary DI
B8034604370
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 46-0437
Catalog number
OM 46-0437
Device description
COBB CURETTE CVD. 11" #2 ALU HDLE
Published
2021-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTFCurette

Product Code Classifications

CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B8034604370PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
503-234-9691SUPPORT@ORTHOMEDINC.COM

Regulatory Flags

DUNS number
086618626
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
B8035200860ORTHOMEDOM 52-00862026-02-18
B8035200870ORTHOMEDOM 52-00872026-02-18
B8035200880ORTHOMEDOM 52-00882026-02-18
B8035200900ORTHOMEDOM 52-00902026-02-18
B8035200920ORTHOMEDOM 52-00922026-02-18
B8035200930ORTHOMEDOM 52-00932026-02-18
B8035200940ORTHOMEDOM 52-00942026-02-18
B8035201160ORTHOMEDOM 52-01162026-02-18
B8035201180ORTHOMEDOM 52-01182026-02-18
B8035201220ORTHOMEDOM 52-01222026-02-18
B8035201240ORTHOMEDOM 52-01242026-02-18
B8035201280ORTHOMEDOM 52-01282026-02-18
B8035201300ORTHOMEDOM 52-01302026-02-18
B8035201980ORTHOMEDOM 52-01982026-02-18
B8035202020ORTHOMEDOM 52-02022026-02-18
B8035202040ORTHOMEDOM 52-02042026-02-18
B8035202060ORTHOMEDOM 52-02062026-02-18
B8035105300ORTHOMEDOM 51-05302026-02-09
B8035105320ORTHOMEDOM 51-05322026-02-09
B8035105340ORTHOMEDOM 51-05342026-02-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
24026704941692PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
24026704941708PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
00192896122871Spoon CuretteSONTEC INSTRUMENTS, INC.HTF2026-03-19
00810158219052PRINCETONPrinceton Medical Group, Inc.HTF2026-03-11
00190776393229MillenniumAvalign Technologies, Inc.HTF2026-03-04
00810168190297NAPACIFIC INSTRUMENTS, INC.HTF2026-03-03
00190776417260MillenniumAvalign Technologies, Inc.HTF2026-02-20
00190776416447MillenniumAvalign Technologies, Inc.HTF2026-02-16
00190776416669MillenniumAvalign Technologies, Inc.HTF2026-02-16
03662663109475Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109512Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109529Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109543Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109550Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109567Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
00190776416010MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416027MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416041MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416058MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416065MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776415785MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415792MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415808MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415815MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415822MillenniumAvalign Technologies, Inc.HTF2026-02-04
03662663083584ActivLHighridge Medical, LLCHTF2026-02-03
03662663083591ActivLHighridge Medical, LLCHTF2026-02-03
03662663083607ActivLHighridge Medical, LLCHTF2026-02-03
03662663083614ActivLHighridge Medical, LLCHTF2026-02-03
03662663083621ActivLHighridge Medical, LLCHTF2026-02-03