DDP Microtome Set Microtome Kit (18)

GUDID 00083208171123

Set of 18 hand-held, manual, one-piece surgical instruments intended to split/force apart bones in the face, mouth and/or jaws (e.g., palate, mandibular inferior border) during maxillofacial surgery (e.g., sagittal split osteotomy procedure); they are not designed to cut or shape bone (i.e., not an osteotome). They are metal instruments with a handle and a blade at the distal working end. The Kit consists of 18 instruments, including an autoclavable surgical instrument tray.

Suncoast Dental, Inc

Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set Dental osteotome set

Primary Device ID	00083208171123
NIH Device Record Key	63ebf6e7-13ca-460d-a8f4-312466dbbfe9
Commercial Distribution Status	In Commercial Distribution
Brand Name	DDP Microtome Set
Version Model Number	Microtome Kit (18)
Catalog Number	Microtome Kit (18)
Company DUNS	078352849
Company Name	Suncoast Dental, Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
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	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
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	00083208171123 [Primary]

FDA Product Code

EMM	Chisel, Osteotome, Surgical