Extended Worktop - Umbilical Carts - ASI MEDICAL, INC.

Duns Number:808695159

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More Product Details

Catalog Number

90-2044

Brand Name

Extended Worktop - Umbilical Carts

Version/Model Number

90-2044

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

K110481

Product Code Details

Product Code

EIA

Product Code Name

Unit, Operative Dental

Device Record Status

Public Device Record Key

9f047832-fbed-44a4-8a14-950a0e9d4706

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASI MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49