Simpurity

Basic Information

• Brand Name: Simpurity
• Primary DI: 00810040131684
• Version / Model: SNS57208
• Catalog Number: SNS57208
• Company Name: SAFE N' SIMPLE LLC
• Labeler DUNS: 807812412
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-05
• Public Version: 1
• Public Version Date: 2023-02-13
• Public Version Status: New
• Public Device Record Key: 029b12d1-3689-48b7-8bfe-59ef477dc296

Device Description

Simpurity Silicone Transparent Film Dressing 8" x 8"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	878.4025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47772	Scar management dressing, single-use, sterile	A sterile covering made of, or coated with, a silicone-based substance (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of a flexible or elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810040131691	GS1	box	12	In Commercial Distribution
Primary	00810040131684	GS1
Package	00810040131707	GS1	case	192	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	8	Inch
Width	8	Inch