J & J INSTRUMENTS INC - U/MICHIGAN BURNISHER #2 - J & J INSTRUMENTS INC

Duns Number:783328149

Device Description: U/MICHIGAN BURNISHER #2

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More Product Details

Catalog Number

02-720

Brand Name

J & J INSTRUMENTS INC

Version/Model Number

02-720

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EKJ

Product Code Name

Burnisher, Operative

Device Record Status

Public Device Record Key

e6a1f260-4e24-4af8-8e6c-2bd244cf08e9

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 18, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"J & J INSTRUMENTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 840
2 A medical device with a moderate to high risk that requires special controls. 6