Vitalitec Knot Pushers - Surgical Knot Pushers 0530-CSP (O 5 mm, 30 cm, - VITALITEC INTERNATIONAL, INC.

Duns Number:121464288

Device Description: Surgical Knot Pushers 0530-CSP (O 5 mm, 30 cm, Closed Knot Pusher, Straight Tip)

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More Product Details

Catalog Number

-

Brand Name

Vitalitec Knot Pushers

Version/Model Number

0530-CSP

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Device Record Status

Public Device Record Key

b1548e4c-a4bb-4b81-81f3-8a8db450eca2

Public Version Date

January 14, 2019

Public Version Number

1

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