Catalog Number

-

Brand Name

Regen Spray Applicator

Version/Model Number

R-A/NAC1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2021

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

K122122

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

1186950a-2ca8-4172-b221-cf1e78d60163

Public Version Date

November 16, 2021

Public Version Number

2

DI Record Publish Date

August 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-