DUKE DRAINAGE CANNULA - DUKE DRAINAGE CANNULA - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: DUKE DRAINAGE CANNULA

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More Product Details

Catalog Number

190-262

Brand Name

DUKE DRAINAGE CANNULA

Version/Model Number

190-262

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

-

Prescription Use (Rx)

Yes

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

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

f01827e5-61c6-4db9-ab6d-a1a0b5c7e131

Public Version Date

June 24, 2019

Public Version Number

1

DI Record Publish Date

June 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414