Silicone Penrose Straight Drain Tube - FORTUNE MEDICAL INSTRUMENT CORP.

Duns Number:656763489

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More Product Details

Catalog Number

-

Brand Name

Silicone Penrose Straight Drain Tube

Version/Model Number

2011-0045

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

GBP

Product Code Name

Catheter, Multiple Lumen

Device Record Status

Public Device Record Key

e30648c1-a134-47df-af48-0c85c2a1df70

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FORTUNE MEDICAL INSTRUMENT CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 307
2 A medical device with a moderate to high risk that requires special controls. 3