REPEX

GUDID 00860001452518

HILL LABORATORIES CO.

Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table Body arch traction table

• Primary Device ID: 00860001452518
• NIH Device Record Key: 3cd3464e-fb3c-4f94-87f4-839803351983
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REPEX
• Version Model Number: REPEX
• Company DUNS: 002326585
• Company Name: HILL LABORATORIES CO.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	00860001452518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043239

FDA Product Code

• ITH: Equipment, Traction, 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: 2020-02-12
• Device Publish Date: 2020-02-04

Devices Manufactured by HILL LABORATORIES CO.

• 00850058158143 - The SAVE Program: 2024-03-19
• 00850058158006 - HA90R: 2023-11-01
• 00850058158051 - HA90P: 2023-11-01
• 00850058158068 - HA90PH: 2023-11-01
• 00850058158075 - HA90PT: 2023-11-01
• 00850058158082 - HA90V: 2023-11-01
• 00850058158099 - HA90W: 2023-11-01
• 00850058158105 - HI-LO: 2023-11-01