Catalog Number

-

Brand Name

Sureform

Version/Model Number

48230M

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

K211997,K211997

Product Code

GDW

Product Code Name

Staple, implantable

Public Device Record Key

bfb48926-f08d-4ce1-a0fe-e837a1bada4a

Public Version Date

May 19, 2022

Public Version Number

1

DI Record Publish Date

May 11, 2022

Package DI Number

10886874121938

Quantity per Package

12

Contains DI Package

00886874121931

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX