PHENOL APPLICATOR

Basic Information

• Brand Name: PHENOL APPLICATOR
• Primary DI: 00844505008129
• Version / Model: 907
• Company Name: Grace Medical, Inc.
• Labeler DUNS: 030849173
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 5
• Public Version Date: 2021-09-03
• Public Version Status: Update
• Public Device Record Key: 887dbbb7-4ab0-4375-b58f-6116119fc78d
• Distribution End Date: 2021-03-05

Device Description

PHENOL APPLICATOR

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
KCJ	Applicator, Ent	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64011	General-purpose absorbent tip applicator/swab, reusable	A hand-held manual device in the form of a slender handle made of metal intended to hold an absorbent material such as a cotton pledget at its distal end for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is typically used in a healthcare setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844505008129	GS1

Customer Contacts

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