SIERRA ROMER W/OVERDOOR FRAME

Basic Information

• Brand Name: SIERRA ROMER W/OVERDOOR FRAME
• Primary DI: 00610570064281
• Version / Model: 08143641
• Company Name: Bird & Cronin, LLC
• Labeler DUNS: 045975349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-20
• Public Version: 1
• Public Version Date: 2022-08-29
• Public Version Status: New
• Public Device Record Key: 11079dfb-1e8f-42ff-a92f-5360c5d44baf

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
IOD	Components, Exercise	Physical Medicine	890.5350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44231	Upper-limb mechanical weight exerciser, lever/pulley-cable	A mechanical exercise apparatus intended primarily to strengthen the major muscles of the upper limb (e.g., biceps, triceps, deltoids, brachioradialis, wrist flexors and extensors) through a repetitive pushing, pulling, curling, or extending motion performed with the arms/hands against the force of a weight. It typically consists of a metal frame containing a lever or pulley-cable system that incorporates changeable weights and bars and/or handles/hand stirrups for the hands and arms; a bench may be included for the user to sit or lay while performing the exercise. The device may also be used to improve upper limb flexibility and mobility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00610570064281	GS1