8.0mm Nut 380-7000

GUDID 00810074306423

8.0mm Nut

Osteocentric Technologies, Inc.

Orthopaedic bone nut
Primary Device ID00810074306423
NIH Device Record Keyaa7c5617-8572-4fc0-ae4a-605cc2976a5e
Commercial Distribution StatusIn Commercial Distribution
Brand Name8.0mm Nut
Version Model Number380-7000
Catalog Number380-7000
Company DUNS089645059
Company NameOsteocentric Technologies, 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

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
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
GS100810074306423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


[00810074306423]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-07-02
Device Publish Date2024-12-10

Devices Manufactured by Osteocentric Technologies, Inc.

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00810074309974 - 11 X 80mm LAG FASTENER2025-09-30 11 X 80mm LAG FASTENER
00810074309981 - 11 X 85mm LAG FASTENER2025-09-30 11 X 85mm LAG FASTENER
00810074309998 - 11 X 90mm LAG FASTENER2025-09-30 11 X 90mm LAG FASTENER
00810189110007 - 11 X 95mm LAG FASTENER2025-09-30 11 X 95mm LAG FASTENER
00810189110014 - 11 X 100mm LAG FASTENER2025-09-30 11 X 100mm LAG FASTENER
00810189110021 - 11 X 105mm LAG FASTENER2025-09-30 11 X 105mm LAG FASTENER
00810189110038 - 11 X 110mm LAG FASTENER2025-09-30 11 X 110mm LAG FASTENER

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