Catalog Number

-

Brand Name

Sephure® suppository applicator

Version/Model Number

B3-10

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092829,K092829

Product Code

OOW

Product Code Name

Applicator For Rectal Suppository

Public Device Record Key

9886af3e-8f49-4e31-9c71-a8a1e470c044

Public Version Date

October 06, 2021

Public Version Number

1

DI Record Publish Date

September 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-