FDA.report

Impactor

Primary DI
B058ODIU031
Brand
Impactor
Company
Orthopedic Designs North America, Inc.
Model
ODIU03
Catalog number
ODI-U03
Device description
Impactor
Published
2023-06-13
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
HWAImpactor

Product Code Classifications

CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B058ODIU031PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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

Other Devices From This Company

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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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