Rolyan

GUDID 00885914038659

Rolyan Scar Pump

Performance Health Supply, LLC

External manual massager, clinical

• Primary Device ID: 00885914038659
• NIH Device Record Key: f299f05b-9132-4b26-8796-426849a85220
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rolyan
• Version Model Number: 081296003
• Company DUNS: 966806150
• Company Name: Performance Health Supply, LLC
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00885914038659 [Primary]

FDA Product Code

• LYG: Massager, Therapeutic, Manual

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: 2024-10-14
• Device Publish Date: 2024-10-04

Devices Manufactured by Performance Health Supply, LLC

• 00885914107898 - Sammons Preston: 2026-02-02 Sammons Preston Hot/Cold Combo pack, 10.625" x 6", EA
• 00885914107966 - Sammons Preston: 2026-02-02 Sammons Preston Instant Cold Pack, 5.5" x 6.25", EA
• 00885914107973 - Sammons Preston: 2026-02-02 Sammons Preston Instant Cold Pack, 6.5" x 9", EA
• 00885914107980 - Sammons Preston: 2026-02-02 Sammons Preston Instant Cold Pack, Perineal, 5.5" x 14.75", EA
• 00885914107997 - Sammons Preston: 2026-02-02 Sammons Preston Instant Cold Pack, Direct to Skin, 5"x 7.5", EA
• 00885914108000 - Sammons Preston: 2026-02-02 Sammons Preston Instant Cold Pack, Direct to Skin, 6.25"x 9.5", EA
• 00885914108017 - Sammons Preston: 2026-02-02 Sammons Preston Instant Hot Pack, 5.75" x 5.75", EA
• 00885914108024 - Sammons Preston: 2026-02-02 Sammons Preston Instant Hot Pack, 5.75" x 8.5", EA