Silicone Thoracic Drain, SF Type - FORTUNE MEDICAL INSTRUMENT CORP.

Duns Number:656763489

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More Product Details

Catalog Number

-

Brand Name

Silicone Thoracic Drain, SF Type

Version/Model Number

2018-0128

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

GBS

Product Code Name

Catheter, Ventricular, General & Plastic Surgery

Device Record Status

Public Device Record Key

aee70cec-9236-4894-aa75-a41e5989ca8a

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