Catalog Number

X-80619

Brand Name

22G BLK NDLE TIP 15 UNLABELED

Version/Model Number

X-80619

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2020

Issuing Agency

In HIBCC

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

-

Product Code

EID

Product Code Name

SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Public Device Record Key

74f80431-21f8-41e1-b3fa-84a0e62e339b

Public Version Date

December 25, 2020

Public Version Number

4

DI Record Publish Date

November 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-