Catalog Number

S SDDLR 0125 R03606 FAB

Brand Name

First+Aid

Version/Model Number

S SDDLR 0125 R03606 FAB [was S SDDLR 0125 R03606 FBB]

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KXF

Product Code Name

Applicator, Absorbent Tipped, Non-Sterile

Public Device Record Key

21b7146c-29e5-4e59-aae5-dcca18077bdc

Public Version Date

February 04, 2021

Public Version Number

3

DI Record Publish Date

February 28, 2020

Package DI Number

10048341007026

Quantity per Package

36

Contains DI Package

00048341007029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case