Disposable High Easy LOOPS XXLarge

GUDID 05056387415932

SILVALEA LIMITED

General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness General-purpose patient lifting system sling/harness

• Primary Device ID: 05056387415932
• NIH Device Record Key: 9d8acbb7-0b8e-45a6-a3c2-a511ec4ac7e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable High Easy LOOPS XXLarge
• Version Model Number: M921505-XXL
• Company DUNS: 423632996
• Company Name: SILVALEA LIMITED
• 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: true
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056387415932 [Primary]

FDA Product Code

• INE: Sling, Overhead Suspension, Wheelchair

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: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by SILVALEA LIMITED

• 05056387415864 - Disposable High Easy LOOPS Large: 2024-03-19
• 05056387415871 - Disposable High Easy Poly LOOPS Large: 2024-03-19
• 05056387415888 - Disposable High Easy LOOPS MEDIUM: 2024-03-19
• 05056387415895 - Disposable High Easy Poly LOOPS Medium: 2024-03-19
• 05056387415901 - Disposable High Easy LOOPS Small: 2024-03-19
• 05056387415918 - Disposable High Easy LOOPS Extra Large: 2024-03-19
• 05056387415925 - Disposable High Easy LOOPS Extra Small: 2024-03-19
• 05056387415932 - Disposable High Easy LOOPS XXLarge: 2024-03-19
• 05056387415932 - Disposable High Easy LOOPS XXLarge: 2024-03-19