Catalog Number

ILCM 4515

Brand Name

Epikut

Version/Model Number

ILCM 4515

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

K211921

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

65fbc55e-b24c-4d98-98cb-f03d77c2c7a3

Public Version Date

January 25, 2022

Public Version Number

1

DI Record Publish Date

January 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-