Catalog Number

3505SA

Brand Name

Precision

Version/Model Number

3505SA

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)

Yes

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

80daeed3-3b26-41a9-acbb-36a0f76867ee

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

20884527004895

Quantity per Package

10

Contains DI Package

10884527004898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE