NA - Replacement Pad for Axiom Artis Table, Ultracare - David Scott Company

Duns Number:073814568

Device Description: Replacement Pad for Axiom Artis Table, Ultracare

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More Product Details

Catalog Number

DSC-AXIOM-2PC-UC

Brand Name

NA

Version/Model Number

DSC-AXIOM-2PC-UC

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

LWG

Product Code Name

Surgical Table Cushion

Device Record Status

Public Device Record Key

efe0829b-e051-44e3-9d27-eef53ae97480

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DAVID SCOTT COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 264