DeRoyal - LAP CHOLE PACK - DEROYAL INDUSTRIES, INC.

Duns Number:096372255

Device Description: LAP CHOLE PACK

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More Product Details

Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

89-8281

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

Yes

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

FDE

Product Code Name

laparoscopy kit

Device Record Status

Public Device Record Key

c4b8d0c3-ce33-48b1-8e4c-50f5593316e3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

50749756825349

Quantity per Package

2

Contains DI Package

00749756825344

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"DEROYAL INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7041
2 A medical device with a moderate to high risk that requires special controls. 4913
U Unclassified 3