Catalog Number

9L15-0010-A

Brand Name

BaseCap

Version/Model Number

9L15-0010-A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K152454

Product Code

KWD

Product Code Name

Prosthesis, Toe, Hemi-, Phalangeal

Public Device Record Key

ab693069-e83b-49b0-9fc3-4c8598c014f5

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

November 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-