Rachel Harness Mesh Navy Extra Large

GUDID 05056387439488

SILVALEA LIMITED

General-purpose patient lifting system sling/harness

• Primary Device ID: 05056387439488
• NIH Device Record Key: e8312528-43d3-48fd-bad8-c8de510cebbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rachel Harness Mesh Navy Extra Large
• Version Model Number: M921535-XL
• 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: false
• 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	05056387439488 [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: 2024-08-13
• Device Publish Date: 2024-08-05

Devices Manufactured by SILVALEA LIMITED

• 05056387439426 - Rachel Harness Mesh Navy XXXSmall: 2024-08-13
• 05056387439433 - Rachel Harness Mesh Navy XXSmall: 2024-08-13
• 05056387439440 - Rachel Harness Mesh Navy Extra Small: 2024-08-13
• 05056387439457 - Rachel Harness Mesh Navy Small: 2024-08-13
• 05056387439464 - Rachel Harness Mesh Navy Medium: 2024-08-13
• 05056387439471 - Rachel Harness Mesh Navy Large: 2024-08-13
• 05056387439488 - Rachel Harness Mesh Navy Extra Large: 2024-08-13
• 05056387439488 - Rachel Harness Mesh Navy Extra Large: 2024-08-13
• 05056387439495 - In-Situ Deluxe Superfine Double Layer XXXSmall: 2024-08-13