ROLYAN

GUDID 00840216123397

ROLYAN KNEE SEPARATOR W/POLYESTER COVER

Asp Global, LLC

Leg/knee cushion

• Primary Device ID: 00840216123397
• NIH Device Record Key: a21f044f-0bec-4f51-8593-3ece333be134
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROLYAN
• Version Model Number: 081279447
• Company DUNS: 080361159
• Company Name: Asp Global, 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840216123397 [Primary]

FDA Product Code

• FMP: Protector, Skin Pressure

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: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [ROLYAN]

• 00840216112582: Rolyan Low-Tack Polycushion Padding, Beige, 1/8" (3.2mm) 4/PK
• 00840216112575: Rolyan Polycushion Padding, Black, 1/8" (3.2mm) 4/PK
• 00840216112568: Rolyan Polycushion Padding, Beige, 1/8" (3.2mm) 4/PK
• 00840216123397: ROLYAN KNEE SEPARATOR W/POLYESTER COVER