FDA.reportPublic FDA data

Guide Wire Ruler

Primary DI
B058ODIF051
Brand
Guide Wire Ruler
Company
Orthopedic Designs North America, Inc.
Model
ODIF05
Catalog number
ODI-F05
Device description
Guide Wire Ruler
Published
2023-06-13
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
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B058ODIF051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, reusableA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-635-8535support@odi-na.com

Regulatory Flags#

DUNS number
945518848
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B058AHN5026NS1Atlas™ Humeral Nail SystemAHN5026NSAHN-5-026NS2026-05-04
B058AHN5028NS1Atlas™ Humeral Nail SystemAHN5028NSAHN-5-028NS2026-05-04
B058AHN5030NS1Atlas™ Humeral Nail SystemAHN5030NSAHN-5-030NS2026-05-04
B058AHN5032NS1Atlas™ Humeral Nail SystemAHN5032NSAHN-5-032NS2026-05-04
B058AHN11C00L1Atlas™ Humeral Nail SystemAHN11C00LAHN-11-C00-L2025-01-28
B058AHN11C05L1Atlas™ Humeral Nail SystemAHN11C05LAHN-11-C05-L2025-01-28
B058AHN11C10L1Atlas™ Humeral Nail SystemAHN11C10LAHN-11-C10-L2025-01-28
B058ART13C001ART End CapART13C00ART-13-C002021-11-29
B058ART13C051ART End CapART13C05ART-13-C052021-11-29
B058ART13C101ART End CapART13C10ART-13-C102021-11-29
B058ART13C151ART End CapART13C15ART-13-C152021-11-29
B058HTN10C011Talon™ DistalFix™ HTN End CapHTN10C01HTN-10-C012018-03-16
B058HTN10C01L1Talon™ DistalFix™ HTN End Cap LockingHTN10C01LHTN-10-C01-L2019-03-07
B058HTN10C051Talon™ DistalFix™ HTN End CapHTN10C05HTN-10-C052018-03-16
B058HTN10C05L1Talon™ DistalFix™ HTN End Cap LockingHTN10C05LHTN-10-C05-L2019-03-07
B058HTN10C101Talon™ DistalFix™ HTN End CapHTN10C10HTN-10-C102018-03-16
B058HTN10C10L1Talon™ DistalFix™ HTN End Cap LockingHTN10C10LHTN-10-C10-L2019-03-07
B058HTN10C151Talon™ DistalFix™ HTN End CapHTN10C15HTN-10-C152018-03-16
B058HTN10C15L1Talon™ DistalFix™ HTN End Cap LockingHTN10C15LHTN-10-C15-L2019-03-07
B058SLN1550001Talon™ DistalFix™ End CapSLN1550002015-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806373887741BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887758BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887765BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
09348215164577Longboard Trial Neck LOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
09348215164584Longboard Trial Neck SOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
09348215164591Longboard Trial Neck HOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
G791EFTEMPS080WishFIXRed Star Contract Manufacturing Inc.HWT2025-10-06
07613327524536INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524543INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524550INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327548716InstrumentHowmedica Osteonics Corp.HWT2024-02-22
07613327565850INSTRUMENTHowmedica Osteonics Corp.HWT2024-01-08
09348215082017Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082024Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082031Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082048Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082055Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215084998Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085001Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085018Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085025Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085032Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085049Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085056Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085063Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085070Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085087Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085094Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085100Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085117Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20