Barrel Reamer 317-0007

GUDID 00816950029387

Barrel Reamer

SMV SCIENTIFIC LLC

General external orthopaedic fixation system implantation kit, reusable
Primary Device ID00816950029387
NIH Device Record Keyf632beca-bd1c-4d31-96bc-198d0a23d6b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarrel Reamer
Version Model Number317-0007
Catalog Number317-0007
Company DUNS089645059
Company NameSMV SCIENTIFIC LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950029387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


[00816950029387]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-17
Device Publish Date2021-05-07

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00810074300056 - 4.0 x 22mm Screw Super Fastener, ST2023-06-20 4.0 x 22mm Screw Super Fastener, ST
00810074300063 - 4.0 x 24mm Screw Super Fastener, ST2023-06-20 4.0 x 24mm Screw Super Fastener, ST
00810074300070 - 4.0 x 26mm Screw Super Fastener, ST2023-06-20 4.0 x 26mm Screw Super Fastener, ST

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