LITE PROFILE

Basic Information

• Brand Name: LITE PROFILE
• Primary DI: 00857915007613
• Version / Model: 3650
• Company Name: A.M. SURGICAL, INC.
• Labeler DUNS: 160020087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-11
• Public Version: 2
• Public Version Date: 2021-05-13
• Public Version Status: Update
• Public Device Record Key: cc4097ed-d7a1-49c3-834b-72dd62850940

Device Description

LITE PROFILE ENDOSCOPIC RELEASE SYSTEM

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: Yes
• 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
NBH	Accessories, Arthroscopic	Orthopedic	888.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857915007613	GS1
Package	00857915007620	GS1	Case	5	In Commercial Distribution

Customer Contacts

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