Catalog Number

-

Brand Name

Sterile Micro Needle Cartridge

Version/Model Number

Exact RF TIP

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

K211562,K211562,K211562

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

2a91179a-9ffb-4c54-8e24-8ee7252d6778

Public Version Date

December 16, 2021

Public Version Number

1

DI Record Publish Date

December 08, 2021

Package DI Number

08800017100760

Quantity per Package

5

Contains DI Package

08800017100753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-