Domico Med-Device - Spine Tabletop - DOMICO MED-DEVICE, LLC

Duns Number:081253414

Device Description: Spine Tabletop

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More Product Details

Catalog Number

-

Brand Name

Domico Med-Device

Version/Model Number

32588

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

KXJ

Product Code Name

Table, Radiologic

Device Record Status

Public Device Record Key

962514b3-f71f-4a47-b9ee-ef84f0d1a393

Public Version Date

January 24, 2020

Public Version Number

1

DI Record Publish Date

January 16, 2020

Additional Identifiers

Package DI Number

10861001002649

Quantity per Package

1

Contains DI Package

00861001002642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DOMICO MED-DEVICE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 512
2 A medical device with a moderate to high risk that requires special controls. 35