Prometheus Omni Splint Flat PML115

GUDID 05060483570105

The Prometheus Omni Splint™ is intended to be used to aid support and immobilize a patient’s limb(s).

SAFEGUARD MEDICAL TECHNOLOGIES LIMITED

First aid limb splint, mouldable, single-use

• Primary Device ID: 05060483570105
• NIH Device Record Key: 8213b5fb-3efa-4854-9e0e-b84e2c322089
• Commercial Distribution Discontinuation: 2030-05-04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometheus Omni Splint Flat
• Version Model Number: PML115
• Catalog Number: PML115
• Company DUNS: 219545612
• Company Name: SAFEGUARD MEDICAL TECHNOLOGIES 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060483570105 [Primary]

FDA Product Code

• NOC: Splint, Extremity, Non-Inflatable, External, Non-Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Device Record Status: Published
• Public Version Number: 0
• Device Publish Date: 2023-05-04

Devices Manufactured by SAFEGUARD MEDICAL TECHNOLOGIES LIMITED

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