Catalog Number

TOBLER1

Brand Name

ACE Medical

Version/Model Number

TOBLER1

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

-

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

-

Product Code

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Public Device Record Key

b6d12f25-f347-43a4-8750-02c7b24d063f

Public Version Date

September 20, 2022

Public Version Number

2

DI Record Publish Date

June 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-