Catalog Number

-

Brand Name

GUIDING HANDLE

Version/Model Number

18650

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

K101030

Product Code

HWA

Product Code Name

Impactor

Public Device Record Key

cbef246d-ec45-4497-b951-7a4ff7e7d2c3

Public Version Date

June 14, 2019

Public Version Number

1

DI Record Publish Date

June 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-