Silverbolt/Mainframe Instruments

GUDID 00840996156615

SILVERBOLT,ROD REDUCER

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996156615
NIH Device Record Keyaffb275d-4f9b-40b9-bdac-f9b40e7d6185
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilverbolt/Mainframe Instruments
Version Model Number200-7016
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996156615 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996156615]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-24
Device Publish Date2018-11-22

On-Brand Devices [Silverbolt/Mainframe Instruments]

00840996169233S'BOLT,DRIVER,POLY,SOLID,MAINFRAME
00840996169226S'BOLT,CANN,DR,POLY,MAINFRAME
00840996163576SILVERBOLT,TAP, W REAMER TIP, 7.0
00840996163569SILVERBOLT,TAP, W REAMER TIP, 6.0
00840996157469SILVERBOLT,DRIVER, X-15
00840996156615SILVERBOLT,ROD REDUCER
00840996187398SILVERBOLT,TISSUE SPLIT BLD,(2)
00840996181297SILVERBOLT, TAP, W REAMER, 5.5

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