Skytron Spine Frame Pad Set

Basic Information

• Brand Name: Skytron Spine Frame Pad Set
• Primary DI: 00810105030709
• Version / Model: 3-090-01-P
• Company Name: COMPOSITE MANUFACTURING, INC.
• Labeler DUNS: 947090650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-22
• Public Version: 1
• Public Version Date: 2024-04-01
• Public Version Status: New
• Public Device Record Key: 718ec78c-ab72-45d3-9b30-2eafac0851c5

Device Description

Full Pad Set for Skytron Spine Frame.

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
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	878.4950	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	00810105030709	GS1