Vitalitec Clip Appliers - PVC320-E (Medium Large C Applier, 20cm) - VITALITEC INTERNATIONAL, INC.

Duns Number:121464288

Device Description: PVC320-E (Medium Large C Applier, 20cm)

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More Product Details

Catalog Number

-

Brand Name

Vitalitec Clip Appliers

Version/Model Number

PVC320-E

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)

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

HBT

Product Code Name

Applier, Hemostatic Clip

Device Record Status

Public Device Record Key

0fed04ed-b08f-407f-a866-fa717856a8c1

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

December 13, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VITALITEC INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 163
2 A medical device with a moderate to high risk that requires special controls. 72