Catalog Number

-

Brand Name

MedDrain

Version/Model Number

25277

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

Yes

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

K931607,K931607

Product Code

GBN

Product Code Name

Catheter, Pediatric, General & Plastic Surgery

Public Device Record Key

f65d5a01-38b1-4d77-a85e-ae86c9994f63

Public Version Date

December 03, 2018

Public Version Number

1

DI Record Publish Date

November 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-