PRACTIfilm Barrier Cling Sheets Clear

Basic Information

• Brand Name: PRACTIfilm Barrier Cling Sheets Clear
• Primary DI: 00723896018132
• Version / Model: 704222 4X6 Clear FLM
• Catalog Number: 704222
• Company Name: PRACTICON, INC.
• Labeler DUNS: 119193803
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1200
• Record Status: Published
• Publish Date: 2020-08-14
• Public Version: 1
• Public Version Date: 2020-08-24
• Public Version Status: New
• Public Device Record Key: d3fe770e-55a7-424d-9bd1-84fb4943e5f2

Device Description

Clear PRACTIfilm Barrier Cling Sheets are a simple solution to contamination control. Thinner 1.5 mil polyethylene and special low-tack adhesive give PRACTIfilm the ideal cling quality. Each 4" x 6" sheet sticks anywhere yet removes easily, leaving no residue. 1,200 perforated sheets per roll in a convenient dispenser box.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00723896018149	GS1	Case	20	In Commercial Distribution
Primary	00723896018132	GS1
Unit of Use	00723896015155	GS1

Premarket Submissions

Submission Number	Supplement Number
K151123	000