The Locking Pediatric Osteotomy Plate (LolliPOP) System

Basic Information

• Brand Name: The Locking Pediatric Osteotomy Plate (LolliPOP) System
• Primary DI: 07540194008916
• Version / Model: POP-CAP100
• Catalog Number: POP-CAP100
• 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: 75c71c60-3e2c-4786-9514-c7f1c7072c81

Device Description

IMPACTION CAP

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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63884	Surgical instrument protective cap	A small, non-sterile cover designed to be placed on the tip or working end of a surgical instrument to protect it from damage while not in use. It may be made of metal or synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540194008916	GS1

Customer Contacts

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

Storage Conditions

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