FDA.report

ORTHOMED

Primary DI
B8032401180
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 24-0118
Device description
EASY CLEAN DEPTH GAUGE MEASURES 2.0-2.4MM SCREWS 0-30MM MEASUREMENT RANGE
Published
2022-01-05
Public version status
Update
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
HTJGauge, Depth

Product Code Classifications

CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B8032401180PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

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
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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
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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

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