5.2mm Fastener Tap 110470

GUDID 00816950029547

5.2mm Fastener Tap

Osteocentric Technologies, Inc.

Bone tap, reusable
Primary Device ID00816950029547
NIH Device Record Keyeadd50f6-753a-443e-94fc-9e88292589e0
Commercial Distribution StatusIn Commercial Distribution
Brand Name5.2mm Fastener Tap
Version Model Number110470
Catalog Number110470
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
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 Dimensions

Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter
Outer Diameter5.2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950029547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone
HWXTap, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


[00816950029547]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-16
Device Publish Date2024-07-08

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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

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