Imperial Shallow Rectangle Tray - Shallow Rectangle Tray 13x9.64x.75 - Imperial Surgical Ltd

Duns Number:245253575

Device Description: Shallow Rectangle Tray 13x9.64x.75

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More Product Details

Catalog Number

H-0558

Brand Name

Imperial Shallow Rectangle Tray

Version/Model Number

H-0558

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

LRP

Product Code Name

Tray, Surgical

Device Record Status

Public Device Record Key

3983bd13-979a-48df-abd1-0846e43bbbb0

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

December 22, 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