Silon-TSR Face Mask Kit

Basic Information

• Brand Name: Silon-TSR Face Mask Kit
• Primary DI: 00810050460057
• Version / Model: 2200P-K
• Catalog Number: 2200P-K
• Company Name: Bio Med Sciences, Inc.
• Labeler DUNS: 364435974
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-04
• Public Version: 3
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: 526e9d13-a9e6-4c6e-8d13-22ae66c6fd1b

Device Description

Perforated Temporary Skin Replacement Face Mask, Spandage® Tubular Net Dressing, Mastisol® Liquid Adhesion Promoter and5 pks. (2) Sterile 4” x 4” Absorbent Gauze Pads

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MGP	Dressing, Wound And Burn, Occlusive	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58316	Synthetic polymer semi-permeable film dressing, wound-nonadherent	A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed. It may be applied directly to tissue or used in combination with other dressings (e.g., gels) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, shallow ulcers). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810050460054	GS1	Carton	10	In Commercial Distribution
Primary	00810050460057	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K923150	000