Catalog Number

1250-1701

Brand Name

Aries-TC

Version/Model Number

1250-1701

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K181347

Product Code

FZX

Product Code Name

Guide, Surgical, Instrument

Public Device Record Key

7a72e05f-d1b4-4c2a-934e-9841561491db

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

December 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-