TC Pad 10 mm - GALEMED CORPORATION

Duns Number:656854379

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More Product Details

Catalog Number

Sil.Flex

Brand Name

TC Pad 10 mm

Version/Model Number

DP01

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"

-

For Single-Use

-

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

CBH

Product Code Name

Device, Fixation, Tracheal Tube

Device Record Status

Public Device Record Key

8603eae3-ec2c-4ef7-abf5-d736b89ccef6

Public Version Date

March 10, 2021

Public Version Number

3

DI Record Publish Date

October 15, 2015

Additional Identifiers

Package DI Number

64710810117604

Quantity per Package

10

Contains DI Package

24710810117606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"GALEMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 22