n/a

Basic Information

• Brand Name: n/a
• Primary DI: 00858308006282
• Version / Model: S3A1
• Catalog Number: S3A1
• Company Name: Ergonomic Products, Inc.
• Labeler DUNS: 051194887
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-07
• Public Version: 2
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 7bee2419-4d46-478d-b81d-deb07096d977

Device Description

SpriteTx Pediatric Lift Bench

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
NRU	Chair, Dental, Without Operative Unit	Dental	872.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47148	Paediatric dental chair, electric	A mains electricity (AC-powered) device designed to support a paediatric patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858308006282	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius