Catalog Number

-

Brand Name

Poly Splint

Version/Model Number

90050-20

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

K102341

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

d5af283e-dd91-45ad-8441-6b4dd658303f

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

May 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-