Simpurity SNS52244

GUDID 00850004779286

Collagen Dressing 4 x 4 inches

SAFE N' SIMPLE LLC

Collagen wound matrix dressing

• Primary Device ID: 00850004779286
• NIH Device Record Key: 13ea22fa-f71f-448b-a631-a8fbf94035d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpurity
• Version Model Number: SNS52244
• Catalog Number: SNS52244
• Company DUNS: 807812412
• Company Name: SAFE N' SIMPLE LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com
• Phone: 2482144877
• Email: amy@sns-medical.com

Device Dimensions

• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch
• Length: 4 Inch
• Height: 4 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004779286 [Primary]
GS1	00850004779293 [Unit of Use]
GS1	00854261007588 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122325

FDA Product Code

• KGN: Dressing, Wound, Collagen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-08-12