OsteoCentric Headless Compression Screw Fastener Depth Gauge EX01-0004

GUDID 00850015496288

OsteoCentric Headless Compression Screw Fastener Depth Gauge Instrument

Osteocentric Technologies, Inc.

Surgical depth gauge, reusable
Primary Device ID00850015496288
NIH Device Record Key1e042577-c1ba-43d3-a7ef-19b318816730
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoCentric Headless Compression Screw Fastener Depth Gauge
Version Model NumberEX01-0004
Catalog NumberEX01-0004
Company DUNS089645059
Company NameOsteocentric Technologies, Inc.
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 Batchfalse
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
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015496288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

[00850015496288]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-08-16
Device Publish Date2020-06-10

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00810074309233 - POST-LAT DISTAL FIBULA PLATE 4H L2025-05-19 POST-LAT DISTAL FIBULA PLATE 4H L
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