Imperial Double Door Tall / Extended Design, - Double Door Tall / Extended Design, Centre Column - Imperial Surgical Ltd

Duns Number:245253575

Device Description: Double Door Tall / Extended Design, Centre Column

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More Product Details

Catalog Number

OR-3835

Brand Name

Imperial Double Door Tall / Extended Design,

Version/Model Number

OR-3835

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

BZN

Product Code Name

Cart, Emergency, Cardiopulmonary (Excluding Equipment)

Device Record Status

Public Device Record Key

180b32f2-43b0-44bb-bcbf-065ca063e0a0

Public Version Date

January 22, 2021

Public Version Number

1

DI Record Publish Date

January 14, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPERIAL SURGICAL LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 77
2 A medical device with a moderate to high risk that requires special controls. 6