Catalog Number

-

Brand Name

AccuCirc®

Version/Model Number

CIRC-1350

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"

Yes

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

K061539,K061539,K061539

Product Code

HFX

Product Code Name

Clamp, Circumcision

Public Device Record Key

3f167290-275a-4e46-816b-41dd07812c25

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

20814247020097

Quantity per Package

4

Contains DI Package

10814247020090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-