GAP ENDO-EXO MEDULLARY SYSTEM

Basic Information

• Brand Name: GAP ENDO-EXO MEDULLARY SYSTEM
• Primary DI: 07540194010094
• Version / Model: GAP-LGC100
• Catalog Number: GAP-LGC100
• Company Name: Pega Medical Inc
• Labeler DUNS: 257315713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-12
• Public Version: 1
• Public Version Date: 2020-08-20
• Public Version Status: New
• Public Device Record Key: ff77c6b1-5b9b-4353-89dd-873a80eb8387

Device Description

GAP LAG THREAD CUTTER

Device Characteristics

• Single Use: No
• 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: Yes
• 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
HXZ	CUTTER, WIRE	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44805	Orthopaedic implantable-device cutter	A heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540194010094	GS1

Customer Contacts

• Phone: [phone] ext. 242
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep at room temperature