Imperial Overall Dimensions: 33 1/4"L x 28"W x - Overall Dimensions: 33 1/4"L x 28"W x 67"H - Imperial Surgical Ltd

Duns Number:245253575

Device Description: Overall Dimensions: 33 1/4"L x 28"W x 67"H

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More Product Details

Catalog Number

OR-3910C

Brand Name

Imperial Overall Dimensions: 33 1/4"L x 28"W x

Version/Model Number

OR-3910C

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

85fca59f-dd39-4188-b8a9-fbe1a7d2c3d9

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