Arm Sure Shield - X-Ray Shield to ArmSure - ADEPT MEDICAL LIMITED

Duns Number:592534619

Device Description: X-Ray Shield to ArmSure

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More Product Details

Catalog Number

AM0630

Brand Name

Arm Sure Shield

Version/Model Number

AM0630

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

cc596598-6507-429e-b01e-1c2cc1b9a13b

Public Version Date

September 22, 2020

Public Version Number

3

DI Record Publish Date

May 24, 2018

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