FDA.report

Awl

Primary DI
B058ODIF021
Brand
Awl
Company
Orthopedic Designs North America, Inc.
Model
ODIF02
Catalog number
ODI-F02
Device description
Awl
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
HWJAwl

Product Code Classifications

CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B058ODIF021PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

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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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
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B058AHN08180R1Atlas™ Humeral Nail SystemAHN08180RAHN-08-180R2025-01-14

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