Lab Coat - Lab Coat with Pockets, Knitted Cuffs and Collar, - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Lab Coat with Pockets, Knitted Cuffs and Collar, Blue, 2XL

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More Product Details

Catalog Number

-

Brand Name

Lab Coat

Version/Model Number

2076

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"

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

LYU

Product Code Name

Accessory, Surgical Apparel

Device Record Status

Public Device Record Key

023fed20-9e0c-4b8e-b4a7-bdf90e33e9a0

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Additional Identifiers

Package DI Number

00616784207636

Quantity per Package

3

Contains DI Package

00616784207629

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2