2.7 mm Endoscopic Release System

Basic Information

• Brand Name: 2.7 mm Endoscopic Release System
• Primary DI: 00857915007514
• Version / Model: 4500-99
• Company Name: A.M. SURGICAL, INC.
• Labeler DUNS: 160020087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-15
• Public Version: 2
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: d2303ec8-44a3-4a73-bb50-9a39f7a3320f

Device Description

2.7 mm KNIFE & CLEAR CANNULA COMBO PACK

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: 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
58783	Hand ligament surgical release instrument	A hand-held manual surgical instrument designed for use during percutaneous/mini-open surgery to cut a ligament of the hand causing pathological compression. It is typically probe-like in form with a cutting element (e.g., blade, toothed wire) and is typically dedicated to a specific procedure (e.g., carpal tunnel release, trigger finger release). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10857915007511	GS1	Case	5	In Commercial Distribution
Primary	00857915007514	GS1

Customer Contacts

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