Catalog Number

SP-81000

Brand Name

Doyle Spacer Splint

Version/Model Number

SP-81000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 27, 2020

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"

Yes

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

LYA

Product Code Name

Splint, Intranasal Septal

Public Device Record Key

838873ac-04b7-400e-b529-ad0f434cf433

Public Version Date

August 23, 2021

Public Version Number

3

DI Record Publish Date

October 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-