FDA.report

Entry Reamer

Primary DI
B058ODIF031
Brand
Entry Reamer
Company
Orthopedic Designs North America, Inc.
Model
ODIF03
Catalog number
ODI-F03
Device description
Entry Reamer
Published
2023-06-09
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

Related Records

Contact Domains

Product Codes

CodeName
HTOReamer

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B058ODIF031PrimaryHIBCC0

GMDN Terms

TermDefinition
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-635-8535support@odi-na.com

Regulatory Flags

DUNS number
945518848
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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B058AHN5040NS1Atlas™ Humeral Nail SystemAHN5040NSAHN-5-040NS2025-05-23
B058AHN5042NS1Atlas™ Humeral Nail SystemAHN5042NSAHN-5-042NS2025-05-23
B058AHN5044NS1Atlas™ Humeral Nail SystemAHN5044NSAHN-5-044NS2025-05-23
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B058AHN5050NS1Atlas™ Humeral Nail SystemAHN5050NSAHN-5-050NS2025-05-23
B058AHN5052NS1Atlas™ Humeral Nail SystemAHN5052NSAHN-5-052NS2025-05-23
B058SLNT281Lag DrillSLNT28SLN-T282025-04-23
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
B058AHN08180L1Atlas™ Humeral Nail SystemAHN08180LAHN-08-180L2025-01-14
B058AHN08180R1Atlas™ Humeral Nail SystemAHN08180RAHN-08-180R2025-01-14

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