Ergostyle HYLO

GUDID 00850020142149

PIVOTAL HEALTH SOLUTIONS, INC.

Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered Examination/treatment table, line-powered

• Primary Device ID: 00850020142149
• NIH Device Record Key: ac4134b6-1ece-4e9c-830b-23ddffb60e54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ergostyle HYLO
• Version Model Number: EH9510
• Company DUNS: 826316098
• Company Name: PIVOTAL HEALTH SOLUTIONS, INC.
• 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	00850020142149 [Primary]

FDA Product Code

• INQ: Table, Powered

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: 2021-09-06
• Device Publish Date: 2021-08-27

On-Brand Devices [Ergostyle HYLO]

• 00850020142170: EH9540
• 00850020142163: EH9530
• 00850020142156: EH9520
• 00850020142149: EH9510
• 00850020142132: EH9422
• 00850020142125: EH9421
• 00850020142118: EH9420
• 00850020142101: Manual drop HYLO table