Catalog Number

52184-01

Brand Name

Disposable Pre-calibrated Suction Charr. 8

Version/Model Number

52184-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K201752,K201752

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

c162ef86-3d34-4087-8d62-506f3a897093

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Package DI Number

04056481141158

Quantity per Package

10

Contains DI Package

04056481141165

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-