PANTA®

Basic Information

• Brand Name: PANTA®
• Primary DI: 10381780051466
• Version / Model: 519040ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 4
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 5b917830-b407-4df3-af3c-5a5e5b90dae2
• Distribution End Date: 2027-04-19

Device Description

The trocar awl is used to prepare the bone for drilling.

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: 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: Yes
• 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
HWJ	AWL	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15275	Bone awl, reusable	A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248519040ND1	HIBCC
Primary	10381780051466	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4.3mm diameter X 200mm total length