Simpurity SNS52244

GUDID 00850004779286

Collagen Dressing 4 x 4 inches

SAFE N' SIMPLE LLC

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing 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

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

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

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