SUMMIT MEDICAL

Basic Information

• Brand Name: SUMMIT MEDICAL
• Primary DI: 00385640053761
• Version / Model: 3-TT-FILTRON 500
• Company Name: Summit Medical, Inc.
• Labeler DUNS: 965484699
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-20
• Public Version: 3
• Public Version Date: 2022-02-14
• Public Version Status: Update
• Public Device Record Key: 93f5b492-8bbd-44bd-8196-104694415045

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63046	Autologous adipose tissue collection/injection set	A collection of sterile devices intended for both harvesting fat tissue from a patient and subsequently injecting the fat tissue into the patient from which it was taken (autologous) for aesthetic body contouring during reconstructive/cosmetic surgery. It typically consists of various needles/cannulae, syringes, and accessories (e.g., caps, connectors). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385640053761	GS1
Package	10385640053768	GS1	BOX	1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K092482	000