Catalog Number

102-1091

Brand Name

Pitch-Patch

Version/Model Number

102-1091

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K211563

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

6369ca02-adb3-4ac2-bbe5-186314e6478a

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

September 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-