Safe N Simple SNS7610228

GUDID 00810040133480

9" Urostomy One Piece Pouch Extended Wear Convex Transparent 7/8" Pre Cut Stoma Opening with valve and Belt Tabs

SAFE N' SIMPLE LLC

One-piece urostomy bag, open-ended

• Primary Device ID: 00810040133480
• NIH Device Record Key: b763498f-919c-41f3-93ef-2bd1f36ba39d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe N Simple
• Version Model Number: SNS7610228
• Catalog Number: SNS7610228
• Company DUNS: 807812412
• Company Name: SAFE N' SIMPLE LLC
• Device Count: 80
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com
• Phone: 248 214 4877
• Email: amy@sns-medical.com

Device Dimensions

• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch
• Length: 9 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810040133480 [Unit of Use]
GS1	00810040133497 [Primary]
GS1	00810040133503 [Primary]

FDA Product Code

• EXG: Bag, Urine Collecting, Ureterostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-09
• Device Publish Date: 2023-11-01