J & J INSTRUMENTS - AMALGAM CARRIER DE REG/LAR - J & J INSTRUMENTS INC

Duns Number:783328149

Device Description: AMALGAM CARRIER DE REG/LAR

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More Product Details

Catalog Number

01-030

Brand Name

J & J INSTRUMENTS

Version/Model Number

01-030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

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

EKI

Product Code Name

Carrier, Amalgam, Operative

Device Record Status

Public Device Record Key

77c72781-1a8d-4810-839b-ac271f2ceefc

Public Version Date

June 25, 2018

Public Version Number

1

DI Record Publish Date

May 25, 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