Catalog Number

-

Brand Name

ShangRing

Version/Model Number

A1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121789,K121789,K121789

Product Code

HFX

Product Code Name

Clamp, Circumcision

Public Device Record Key

da6c552b-904a-4218-8b01-2e738b5ab109

Public Version Date

March 29, 2021

Public Version Number

1

DI Record Publish Date

March 19, 2021

Package DI Number

26939550822375

Quantity per Package

10

Contains DI Package

16939550822378

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-