Safe N Simple

Basic Information

• Brand Name: Safe N Simple
• Primary DI: 00810040134098
• Version / Model: SNS7832214
• Catalog Number: SNS7832214
• Company Name: SAFE N' SIMPLE LLC
• Labeler DUNS: 807812412
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-10-20
• Public Version: 1
• Public Version Date: 2023-10-30
• Public Version Status: New
• Public Device Record Key: f43c702b-49c1-4741-bb81-343cab8a5b21

Device Description

5" x 5" 2-Piece Wafer Extended Wear Convex with Tape Collar Beige 57mm 2 1/4" Flange 1 1/4" Pre Cut Stoma Opening

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48158	Intestinal ostomy base plate, convex	A non-sterile device designed with a convex surface intended to be applied and adhered to peristomal skin to facilitate correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. The convexity of the device is used to improve peristomal skin contact of a flush stoma or more typically a recessed stoma. It is typically self-applied by the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810040134081	GS1
Primary	00810040134098	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	5	Inch
Length	5	Inch