Catalog Number

-

Brand Name

XP-Seal

Version/Model Number

XP-2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K200623

Product Code

NPL

Product Code Name

Barrier, Animal Source, Intraoral

Public Device Record Key

b670fc1b-2f16-483a-b5ed-4dfe000bc697

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-