Summit Single Use Surgical Arthroscope

Basic Information

• Brand Name: Summit Single Use Surgical Arthroscope
• Primary DI: 10860003634605
• Version / Model: PS-ART001
• Company Name: Pristine Surgical LLC
• Labeler DUNS: 080976458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2024-05-20
• Public Version: 1
• Public Version Date: 2024-05-28
• Public Version Status: New
• Public Device Record Key: 7904487e-de6b-4bd0-83a1-f691fb0e2c21

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
HRX	Arthroscope	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62570	Rigid optical arthroscope, single-use	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint [e.g., knee, shoulder, elbow, temporomandibular joint (TMJ)]. It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structural damage to a joint, often from sports injuries. The eyepiece is normally interfaced with a video camera. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10860003634605	GS1
Unit of Use	00860003634608	GS1

Premarket Submissions

Submission Number	Supplement Number
K223244	000