Silicone Hubless Endo Drain Kit (J Connector+Trocar) - FORTUNE MEDICAL INSTRUMENT CORP.

Duns Number:656763489

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More Product Details

Catalog Number

-

Brand Name

Silicone Hubless Endo Drain Kit (J Connector+Trocar)

Version/Model Number

2015-9721J

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

GCD

Product Code Name

Connector, Catheter

Device Record Status

Public Device Record Key

18bef5c0-c5a9-4cfe-8364-35b80f6d6fd9

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

January 07, 2022

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