Tatum Surgical Bone Fixation Screw Kit E-Z Bone Fixation Screw Kit

GUDID 00083208000003

Bone Fixation Self-Drilling Screw kit with various size of bone screw for securing bone blocks Tatum EZ-Fixation Bone Screw Kit. Includes: Cassette, Driver handle, Driver Tip, Latch grip driver tip, (5) 8mm, (5) 10mm, (5) 12mm, and (3) 14mm Screws, 1.0 and 1.8 Drill.

Suncoast Dental, Inc

Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile

Primary Device ID	00083208000003
NIH Device Record Key	3cd90f1b-78f6-4cc7-a6b8-7356ba4cdfac
Commercial Distribution Status	In Commercial Distribution
Brand Name	Tatum Surgical Bone Fixation Screw Kit
Version Model Number	E-Z bone Fixation Screw Kit
Catalog Number	E-Z Bone Fixation Screw Kit
Company DUNS	078352849
Company Name	Suncoast Dental, Inc
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	true
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	(727) 536-4880
Email	tatumimplants@verizon.net
Phone	(727) 536-4880
Email	tatumimplants@verizon.net
Phone	(727) 536-4880
Email	tatumimplants@verizon.net
Phone	(727) 536-4880
Email	tatumimplants@verizon.net
Phone	(727) 536-4880
Email	tatumimplants@verizon.net
Phone	(727) 536-4880
Email	tatumimplants@verizon.net
Phone	(727) 536-4880
Email	tatumimplants@verizon.net
Phone	(727) 536-4880
Email	tatumimplants@verizon.net
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com
Phone	(727) 536-4880
Email	tatumcompliance@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208000003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141764

FDA Product Code

DZL	Screw, Fixation, Intraosseous