BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX

GUDID 00850072364032

BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX

ORTHO OUTCOMES, LLC

Orthopaedic bone bolt
Primary Device ID00850072364032
NIH Device Record Key49be8c49-4a79-433f-8b43-3551fae8d71d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX
Version Model Number104-0156-01
Company DUNS133439875
Company NameORTHO OUTCOMES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850072364032 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


[00850072364032]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-09
Device Publish Date2026-02-28

Devices Manufactured by ORTHO OUTCOMES, LLC

00850072364032 - BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX2026-03-09BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX
00850072364032 - BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX2026-03-09 BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX
00850072364049 - BOLT, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX2026-03-09 BOLT, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX
00850072364056 - BOLT, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX2026-03-09 BOLT, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX
00850072364063 - BOLT, Ti6Al4V, 7.0mm x 140-160mm, 5mm HEX2026-03-09 BOLT, Ti6Al4V, 7.0mm x 140-160mm, 5mm HEX
00850072364070 - BOLT, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEX2026-03-09 BOLT, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEX
00850072364087 - NUT SLEEVE, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX2026-03-09 NUT SLEEVE, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX
00850072364094 - NUT SLEEVE, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX2026-03-09 NUT SLEEVE, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX
00850072364100 - NUT SLEEVE, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX2026-03-09 NUT SLEEVE, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX

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