Pak-its®

Basic Information

• Brand Name: Pak-its®
• Primary DI: 10381780491897
• Version / Model: 59146
• Catalog Number: DUP59146
• Company Name: Derma Sciences Canada Inc
• Labeler DUNS: 200564891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 3
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 01621751-498d-467a-bc29-4117d91aa5de

Device Description

0.25 in X 5 yards gauze packing iodoform strip in bottles without dispenser insert.

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: No
• 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
FER	Anoscope and accessories	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48129	Gauze strip, antimicrobial	A thin length of woven material (e.g., cotton, cellulose) that is impregnated with an antimicrobial agent (e.g., iodoform) and primarily designed to pack draining wounds to absorb exudates. It may be soaked with other medication (not included) before application. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780491891	GS1	Case	12	In Commercial Distribution
Primary	10381780491897	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.25 in X 5 yards
Device Size Text, specify			0.63 cm X 4.5 m