n/a D1C1

GUDID 00858308006435

SRS Compact Cart - Scaler Not Included

Ergonomic Products, Inc.

Dental delivery system

• Primary Device ID: 00858308006435
• NIH Device Record Key: 2f278edf-2a72-4d6e-b09a-ab455f1a2597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: n/a
• Version Model Number: D1C1
• Catalog Number: D1C1
• Company DUNS: 051194887
• Company Name: Ergonomic Products, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com
• Phone: 1-866-488-4793
• Email: equip@ergonmic-products.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858308006435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132315

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-10-31
• Device Publish Date: 2022-09-07

On-Brand Devices [n/a]

• 00858308006183: Universal Workstation w/ Bien Air MX2 Electric Motor & Controller
• 00858308006176: Universal Assistant Workstation
• 00858308006169: Universal Workstation - No Power Channel
• 00858308006152: Horizon Workstation - No Power Channel
• 00858308006145: Terra Workstation
• 00858308006138: Terra Assistant Workstation
• 00858308006121: Terra Workstation - No Power Channel
• 00858308006114: Stratus Workstation
• 00858308006107: Stratus Workstation w/ Bien Air MX2 Electric Motor & Controller
• 00858308006091: Stratus Assistant Workstation
• 00858308006251: SpriteTx Pediatric Lift Bench
• 00858308006244: EP 310 No Heat, Massage Only - Seamless
• 00858308006237: EP 330 Heat & Massage Only - Seamless
• 00858308006220: EP 370 Traversing Patient Chair - Seamless
• 00858308006213: EP 390 Heat, Massage & Traversing Patient Chair
• 00858308006206: Fast Track LS
• 00858308006190: Aurora LS
• 00858308006084: Stratus Workstation - No Power Channel
• 00858308006077: SRS Compact Cart - Scaler Not Included
• 00858308006060: 32" Hygiene Inwall Top Tier Add On
• 00858308006053: Arc Over the Patient Delivery Unit
• 00858308006046: 32" Hygiene Inwall Workstation - Short
• 00858308006039: Horizon Assistant Workstation
• 00858308006022: Horizon Workstation
• 00858308006008: Universal Workstation
• 00858308006329: Horizon Workstation
• 00858308006312: Universal Workstation - No Power Channel
• 00858308006305: Universal Workstation w/ Bien Air MX2 Electric Motor & Controller
• 00858308006299: Universal Assistant Workstation
• 00858308006282: SpriteTx Pediatric Lift Bench
• 00858308006275: Aurora LS
• 00858308006268: Universal Workstation
• 00858308006503: 32" Hygiene Inwall Top Tier Add On
• 00858308006497: 32" Hygiene Inwall Workstation - Short
• 00858308006480: Arc Over the Patient Delivery Unit
• 00858308006473: EP 310 No Heat, Massage Only - Seamless
• 00858308006466: EP 330 Heat & Massage Only - Seamless
• 00858308006459: EP 370 Traversing Patient Chair - Seamless
• 00858308006442: EP 390 Heat, Massage & Traversing Patient Chair
• 00858308006435: SRS Compact Cart - Scaler Not Included
• 00858308006428: Fast Track LS
• 00858308006411: Stratus Assistant Workstation
• 00858308006404: Horizon Assistant Workstation
• 00858308006398: Horizon Workstation - No Power Channel
• 00858308006381: Stratus Workstation
• 00858308006374: Stratus Workstation - No Power Channel
• 00858308006367: Stratus Workstation w/ Bien Air MX2 Electric Motor & Controller
• 00858308006350: Terra Assistant Workstation
• 00858308006343: Terra Workstation
• 00858308006336: Terra Workstation - No Power Channel