Catalog Number

GIA8048RL

Brand Name

Reliamax

Version/Model Number

GIA8048RL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K122781,K122781

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

936ed312-9497-4adc-b974-dc312b57d4c9

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

September 01, 2015

Package DI Number

10884521168640

Quantity per Package

6

Contains DI Package

20884521168647

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE