FDA.reportPublic FDA data

6.1mm Reamer

Primary DI
B058ODIT1351
Brand
6.1mm Reamer
Company
Orthopedic Designs North America, Inc.
Model
ODIT135
Catalog number
ODI-T135
Device description
6.1mm Reamer
Published
2023-05-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B058ODIT1351PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, reusableA shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. 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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B058AHN08255L1Atlas™ Humeral Nail SystemAHN08255LAHN-08-255L2025-06-17
B058AHN08255R1Atlas™ Humeral Nail SystemAHN08255RAHN-08-255R2025-06-17
B058AHN08270L1Atlas™ Humeral Nail SystemAHN08270LAHN-08-270L2025-06-17
B058AHN08270R1Atlas™ Humeral Nail SystemAHN08270RAHN-08-270R2025-06-17
B058AHN5034NS1Atlas™ Humeral Nail SystemAHN5034NSAHN-5-034NS2025-05-23
B058AHN5036NS1Atlas™ Humeral Nail SystemAHN5036NSAHN-5-036NS2025-05-23
B058AHN5038NS1Atlas™ Humeral Nail SystemAHN5038NSAHN-5-038NS2025-05-23
B058AHN5040NS1Atlas™ Humeral Nail SystemAHN5040NSAHN-5-040NS2025-05-23
B058AHN5042NS1Atlas™ Humeral Nail SystemAHN5042NSAHN-5-042NS2025-05-23
B058AHN5044NS1Atlas™ Humeral Nail SystemAHN5044NSAHN-5-044NS2025-05-23
B058AHN5046NS1Atlas™ Humeral Nail SystemAHN5046NSAHN-5-046NS2025-05-23
B058AHN5048NS1Atlas™ Humeral Nail SystemAHN5048NSAHN-5-048NS2025-05-23
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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