Imperial Perforated Deep Rectangle Tray - Perforated Deep Rectangle Tray 15" - Imperial Surgical Ltd

Duns Number:245253575

Device Description: Perforated Deep Rectangle Tray 15"

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More Product Details

Catalog Number

H-0564P

Brand Name

Imperial Perforated Deep Rectangle Tray

Version/Model Number

H-0564P

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

cf023dc1-bc75-49bb-b173-7f21275eb235

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