Rex Mallet 04570012-101

GUDID D894045700121010

Orthopaedic implant impactor, reusable

Primary Device ID	D894045700121010
NIH Device Record Key	26d90693-0b61-4ce2-a47f-714f43e678ed
Commercial Distribution Status	In Commercial Distribution
Brand Name	Rex Mallet
Version Model Number	P. Striker/Remover
Catalog Number	04570012-101
Company DUNS	080746478
Company Name	Rex Implants, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -10 Degrees Celsius and 70 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	D894045700121010 [Primary]

GEY	Motor, Surgical Instrument, Ac-Powered