Adept Medical STARBoard and STARSupport - Support Patient arm - ADEPT MEDICAL LIMITED

Duns Number:592534619

Device Description: Support Patient arm

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More Product Details

Catalog Number

AM100E

Brand Name

Adept Medical STARBoard and STARSupport

Version/Model Number

E

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

3e96521c-a3f7-44d4-bea3-c2ac421c6d3f

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADEPT MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 33