n/a - EP 310 No Heat, Massage Only - Seamless - Ergonomic Products, Inc.

Duns Number:051194887

Device Description: EP 310 No Heat, Massage Only - Seamless

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More Product Details

Catalog Number

S1A4

Brand Name

n/a

Version/Model Number

S1A4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NRU

Product Code Name

Chair, Dental, Without Operative Unit

Device Record Status

Public Device Record Key

bf9e3f2e-b796-46d4-ac65-f28b03023b35

Public Version Date

October 31, 2022

Public Version Number

2

DI Record Publish Date

September 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ERGONOMIC PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25