Vilex Dual Thread Screw

GUDID 00841731101853

Screw, Headless 8.0x145mm_Ti Green

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00841731101853
NIH Device Record Key6395305a-0a4a-4a8d-b91d-b2bcf0311932
Commercial Distribution StatusIn Commercial Distribution
Brand NameVilex Dual Thread Screw
Version Model NumberF80-145T-20
Company DUNS152008371
Company NameVILEX IN TENNESSEE, INC.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841731101853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841731101853]

Moist Heat or Steam Sterilization

[00841731101853]

Moist Heat or Steam Sterilization

[00841731101853]

Moist Heat or Steam Sterilization

[00841731101853]

Moist Heat or Steam Sterilization

[00841731101853]

Moist Heat or Steam Sterilization

[00841731101853]

Moist Heat or Steam Sterilization

[00841731101853]

Moist Heat or Steam Sterilization

[00841731101853]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-27

On-Brand Devices [Vilex Dual Thread Screw]

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00841731106902Screw, Headless 2.0x29mm_Ti Green
00841731106896Screw, Headless 5.0x100mm XST_Ti Blue
00841731102232Screw Headless 9.0x090mm_Ti Green
00841731102225Screw Headless 9.0x080mm_Ti Green
00841731102218Screw Headless 9.0x070mm_Ti Green
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00841731102164Screw Headless 9.0x150mm_Ti Green
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00841731102133Screw Headless 9.0x120mm_Ti Green
00841731102126Screw Headless 9.0x110mm_Ti Green
00841731102119Screw Headless 9.0x100mm_Ti Green
00841731102102Screw, Headless 8.0x095mm ST_Ti Green
00841731102096Screw, Headless 8.0x095mm_Ti Green
00841731102089Screw, Headless 8.0x090mm ST_Ti Green
00841731102072Screw, Headless 8.0x090mm_Ti Green
00841731102065Screw, Headless 8.0x085mm ST_Ti Green
00841731102058Screw, Headless 8.0x085mm_Ti Green
00841731102041Screw, Headless 8.0x080mm ST_Ti Green
00841731102034Screw, Headless 8.0x080mm_Ti Green
00841731102027Screw, Headless 8.0x075mm ST_Ti Green
00841731102010Screw, Headless 8.0x075mm_Ti Green
00841731102003Screw, Headless 8.0x070mm ST_Ti Green
00841731101990Screw, Headless 8.0x070mm_Ti Green
00841731101983Screw, Headless 8.0x065mm ST_Ti Green
00841731101976Screw, Headless 8.0x060mm ST_Ti Green
00841731101969Screw, Headless 8.0x055mm ST_Ti Green
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