Rolyan N/A

GUDID 00885914040485

Rolyan Ezemix Elastomer Putty Kit 1 x 200 gram Base, 1 x 20 gram Catalyst

Performance Health Supply, LLC

Scar-management dressing, reusable

• Primary Device ID: 00885914040485
• NIH Device Record Key: 9e137eb2-61c6-4b2c-8e6d-7e50fb2102c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rolyan
• Version Model Number: 081301654
• Catalog Number: N/A
• Company DUNS: 966806150
• Company Name: Performance Health Supply, LLC
• Device Count: 1
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885914040485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901991

FDA Product Code

• MDA: Elastomer, Silicone, For Scar Management

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: 2026-03-30
• Device Publish Date: 2026-03-20

On-Brand Devices [Rolyan]

• 00885914038659: Rolyan Scar Pump
• 00885914040485: Rolyan Ezemix Elastomer Putty Kit 1 x 200 gram Base, 1 x 20 gram Catalyst
• 00885914040478: Rolyan 50/50 Mix Elastomer Putty Kit 1 x 424 gram Base, 1 x 424 gram Catalyst
• 00885914040461: Rolyan 50/50 Elastomer Putty Kit 1 x 120 gram Base, 1 x 120 gram Catalyst