N/A - SHIPPERT MEDICAL TECHNOLOGIES, INC

Duns Number:051437143

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

3-C-1H1-3X20

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)

-

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

3f1cc588-b507-4048-bbfe-d07a1597c7d5

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 18, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHIPPERT MEDICAL TECHNOLOGIES, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 567
2 A medical device with a moderate to high risk that requires special controls. 13