Harmony Open Bay Workstation D1H1

GUDID 00858308006534

Harmony Open Bay Workstation

Ergonomic Products, Inc.

Dental delivery system

• Primary Device ID: 00858308006534
• NIH Device Record Key: 2c387821-951c-478f-97cb-1a2e665a03e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony Open Bay Workstation
• Version Model Number: D1H1
• Catalog Number: D1H1
• 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: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-products.com
• Phone: 1-866-488-4796
• Email: equip@ergonomic-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858308006534 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-23
• Device Publish Date: 2025-04-15

Devices Manufactured by Ergonomic Products, Inc.

• 00858308006534 - Harmony Open Bay Workstation: 2025-04-23Harmony Open Bay Workstation
• 00858308006534 - Harmony Open Bay Workstation: 2025-04-23 Harmony Open Bay Workstation
• 00858308006527 - N/A: 2023-06-14 Ortho Deck 24
• 00858308006336 - n/a: 2022-10-31 Terra Workstation - No Power Channel
• 00858308006343 - n/a: 2022-10-31 Terra Workstation
• 00858308006350 - n/a: 2022-10-31 Terra Assistant Workstation
• 00858308006367 - n/a: 2022-10-31 Stratus Workstation w/ Bien Air MX2 Electric Motor & Controller
• 00858308006374 - n/a: 2022-10-31 Stratus Workstation - No Power Channel
• 00858308006381 - n/a: 2022-10-31 Stratus Workstation