DDP Microtome Set

Basic Information

• Brand Name: DDP Microtome Set
• Primary DI: 00083208171123
• Version / Model: Microtome Kit (18)
• Catalog Number: Microtome Kit (18)
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-10
• Public Version: 1
• Public Version Date: 2022-03-18
• Public Version Status: New
• Public Device Record Key: 63ebf6e7-13ca-460d-a8f4-312466dbbfe9

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMM	Chisel, Osteotome, Surgical	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44886	Dental osteotome set	A collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083208171123	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]