Assembly Required Distributors - Back Assm. for all stainless steel stool - ASSEMBLY REQUIRED DISTRIBUTORS INC

Duns Number:170562396

Device Description: Back Assm. for all stainless steel stool

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More Product Details

Catalog Number

-

Brand Name

Assembly Required Distributors

Version/Model Number

CHM8907-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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"

Yes

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

FZM

Product Code Name

Stool, Operating-Room

Device Record Status

Public Device Record Key

3321146b-532e-4384-b24f-919e57464f8e

Public Version Date

September 27, 2018

Public Version Number

1

DI Record Publish Date

August 27, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASSEMBLY REQUIRED DISTRIBUTORS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 8