SINGLE ARM TRAPEZE ASSEMBLY

Basic Information

• Brand Name: SINGLE ARM TRAPEZE ASSEMBLY
• Primary DI: 00850520008006
• Version / Model: ASM100105
• Company Name: KREG MEDICAL INC.
• Labeler DUNS: 079220324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 1
• Public Version Date: 2018-10-22
• Public Version Status: New
• Public Device Record Key: 4435de7b-9377-4a42-bcf6-b4f51cdab720

Device Description

Single Arm Trapeze

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: Yes
• 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
ILZ	Accessories, Traction	Physical Medicine	890.5925	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46525	Bed traction frame	An adjustable support structure usually attached to a patient's bed and designed for management of various orthopaedic conditions. It typically consists of a steel tubing structure that includes brackets and/or pulleys; it includes a post for the headboard and/or footboard, and often an adjustable-length top bar or rail with a hanging trapeze. The device is designed for use in combination with weights and/or other attachments to produce the desired traction in patients while permitting some freedom of motion. It is used to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).	No	Active
11638	Trapeze bar exerciser	A full-body exercise apparatus designed to improve the range of motion around the joints by stretching the major muscle groups in the body using bars. It may consist of short moveable bars that hang from springs supported by a metal frame installed on a horizontal table, or of trapezoid-like steel bars that hang from chains supported by a metal frame attached to a bed; both assist in stretching exercises of the upper limbs, trunk, and lower limbs, and also help users to change position in bed. The device is mainly intended to improve the flexibility of muscles; it can also increase muscle strength, balance, and coordination, and/or increase cardiovascular endurance.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850520008006	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]