DISTRACTOR TOP HANDLE 101-0029

GUDID 00810097802445

DISTRACTOR TOP HANDLE

SMV SCIENTIFIC LLC

Orthopaedic instrument surgical connector
Primary Device ID00810097802445
NIH Device Record Keyca734c3c-094c-4d53-a55c-988e3bf4a1dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISTRACTOR TOP HANDLE
Version Model Number101-0029
Catalog Number101-0029
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
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097802445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


[00810097802445]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-25
Device Publish Date2023-04-17

On-Brand Devices [DISTRACTOR TOP HANDLE]

00810097802445DISTRACTOR TOP HANDLE
00810097802438DISTRACTOR TOP HANDLE

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