n/a D2A1

GUDID 00858308006497

32" Hygiene Inwall Workstation - Short

Ergonomic Products, Inc.

Dental delivery system
Primary Device ID00858308006497
NIH Device Record Key362deac1-6308-463c-a84f-e2a1ee22b73f
Commercial Distribution StatusIn Commercial Distribution
Brand Namen/a
Version Model NumberD2A1
Catalog NumberD2A1
Company DUNS051194887
Company NameErgonomic Products, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com
Phone1-866-488-4793
Emailequip@ergonmic-products.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100858308006497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUnit, Operative Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-10-31
Device Publish Date2022-09-07

On-Brand Devices [n/a]

00858308006183Universal Workstation w/ Bien Air MX2 Electric Motor & Controller
00858308006176Universal Assistant Workstation
00858308006169Universal Workstation - No Power Channel
00858308006152Horizon Workstation - No Power Channel
00858308006145Terra Workstation
00858308006138Terra Assistant Workstation
00858308006121Terra Workstation - No Power Channel
00858308006114Stratus Workstation
00858308006107Stratus Workstation w/ Bien Air MX2 Electric Motor & Controller
00858308006091Stratus Assistant Workstation
00858308006251SpriteTx Pediatric Lift Bench
00858308006244EP 310 No Heat, Massage Only - Seamless
00858308006237EP 330 Heat & Massage Only - Seamless
00858308006220EP 370 Traversing Patient Chair - Seamless
00858308006213EP 390 Heat, Massage & Traversing Patient Chair
00858308006206Fast Track LS
00858308006190Aurora LS
00858308006084Stratus Workstation - No Power Channel
00858308006077SRS Compact Cart - Scaler Not Included
0085830800606032" Hygiene Inwall Top Tier Add On
00858308006053Arc Over the Patient Delivery Unit
0085830800604632" Hygiene Inwall Workstation - Short
00858308006039Horizon Assistant Workstation
00858308006022Horizon Workstation
00858308006008Universal Workstation
00858308006329Horizon Workstation
00858308006312Universal Workstation - No Power Channel
00858308006305Universal Workstation w/ Bien Air MX2 Electric Motor & Controller
00858308006299Universal Assistant Workstation
00858308006282SpriteTx Pediatric Lift Bench
00858308006275Aurora LS
00858308006268Universal Workstation
0085830800650332" Hygiene Inwall Top Tier Add On
0085830800649732" Hygiene Inwall Workstation - Short
00858308006480Arc Over the Patient Delivery Unit
00858308006473EP 310 No Heat, Massage Only - Seamless
00858308006466EP 330 Heat & Massage Only - Seamless
00858308006459EP 370 Traversing Patient Chair - Seamless
00858308006442EP 390 Heat, Massage & Traversing Patient Chair
00858308006435SRS Compact Cart - Scaler Not Included
00858308006428Fast Track LS
00858308006411Stratus Assistant Workstation
00858308006404Horizon Assistant Workstation
00858308006398Horizon Workstation - No Power Channel
00858308006381Stratus Workstation
00858308006374Stratus Workstation - No Power Channel
00858308006367Stratus Workstation w/ Bien Air MX2 Electric Motor & Controller
00858308006350Terra Assistant Workstation
00858308006343Terra Workstation
00858308006336Terra Workstation - No Power Channel
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