Ergobasic Adjustment Table

Basic Information

• Brand Name: Ergobasic Adjustment Table
• Primary DI: 00850008449673
• Version / Model: EB9050
• Company Name: PIVOTAL HEALTH SOLUTIONS, INC.
• Labeler DUNS: 826316098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-27
• Public Version: 1
• Public Version Date: 2021-09-06
• Public Version Status: New
• Public Device Record Key: 8178c045-af36-4067-88f3-d93ab1557a4d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
INW	Table, Mechanical	Physical Medicine	890.3750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46762	Traction table, manual	A mobile, manually-operated, table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a mechanical altering of the table surface geometry. The surface typically consists of sections that can be raised and lowered to manipulate the curvature of the patient?s spine whilst he/she lies in a supine position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is typically used in a healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850008449673	GS1