PRIMARY DEPTH GAUGE 202-0203

GUDID 00810097803473

PRIMARY DEPTH GAUGE

Osteocentric Technologies, Inc.

Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Primary Device ID00810097803473
NIH Device Record Keyc59a50c8-eade-49cd-9baf-6be90f61db21
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRIMARY DEPTH GAUGE
Version Model Number202-0203
Catalog Number202-0203
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097803473 [Primary]

FDA Product Code

HTJGauge, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


[00810097803473]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-01-15
Device Publish Date2024-06-19

Devices Manufactured by Osteocentric Technologies, Inc.

00810074306430 - Nut Driver2025-01-15 Nut Driver
00810074306454 - 2.7MM GUIDE WIRE DRILL TIP SS 600MM2025-01-15 2.7MM GUIDE WIRE DRILL TIP SS 600MM
00810097802872 - 8.0MM TAP CANN HUD-MOD2025-01-15 8.0MM TAP CANN HUD-MOD
00810097803473 - PRIMARY DEPTH GAUGE2025-01-15PRIMARY DEPTH GAUGE
00810097803473 - PRIMARY DEPTH GAUGE2025-01-15 PRIMARY DEPTH GAUGE
00810074302364 - 120mm Locking Lateral Distal Fibula Plate Left2024-12-17 120mm Locking Lateral Distal Fibula Plate Left
00810074302371 - 140mm Locking Lateral Distal Fibula Plate Left2024-12-17 140mm Locking Lateral Distal Fibula Plate Left
00810074302388 - 120mm Locking Lateral Distal Fibula Plate Right2024-12-17 120mm Locking Lateral Distal Fibula Plate Right
00810074302395 - 140mm Locking Lateral Distal Fibula Plate Right2024-12-17 140mm Locking Lateral Distal Fibula Plate Right

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.