iTrac

GUDID 00852753008945

itrac 115V

PIVOTAL HEALTH SOLUTIONS, INC.

Traction table, line-powered

• Primary Device ID: 00852753008945
• NIH Device Record Key: 86e8e99b-6f4a-40cf-a564-56802d9697d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTrac
• Version Model Number: T9000
• Company DUNS: 826316098
• Company Name: PIVOTAL HEALTH SOLUTIONS, INC.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852753008945 [Primary]

FDA Product Code

• ILZ: Accessories, Traction

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: 2018-11-16
• Device Publish Date: 2018-10-16

On-Brand Devices [iTrac]

• 00852753008952: iTrac, 230V
• 00852753008945: itrac 115V