Catalog Number

EP01

Brand Name

RELIEVA CIRCA

Version/Model Number

EP01

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

-

Product Code

KAX

Product Code Name

PUNCH, ETHMOID

Public Device Record Key

2c78043d-d95a-4042-99c8-10180172c2ef

Public Version Date

October 28, 2021

Public Version Number

5

DI Record Publish Date

October 01, 2016

Package DI Number

20705031230986

Quantity per Package

5

Contains DI Package

10705031230989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX