Storage Cabinet - A device to store endoscopes. - CUSTOM ULTRASONICS, INCORPORATED

Duns Number:029526795

Device Description: A device to store endoscopes.

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More Product Details

Catalog Number

-

Brand Name

Storage Cabinet

Version/Model Number

20000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JRJ

Product Code Name

Unit, Drying

Device Record Status

Public Device Record Key

fac7a9f9-5746-441d-8a83-93eda4883e30

Public Version Date

September 15, 2021

Public Version Number

1

DI Record Publish Date

September 07, 2021

Additional Identifiers

Package DI Number

B215STORAGECABINET20000

Quantity per Package

1

Contains DI Package

STORAGECABINET20000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Crate

"CUSTOM ULTRASONICS, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 4