Arm Support - Reusable non-sterile set of rigid adjustable arm - MEDTEC, INC.

Duns Number:103977526

Device Description: Reusable non-sterile set of rigid adjustable arm supports

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More Product Details

Catalog Number

106015

Brand Name

Arm Support

Version/Model Number

106015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 05, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K060737

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Device Record Status

Public Device Record Key

14be485f-272e-40e0-89f0-27a604505714

Public Version Date

December 05, 2019

Public Version Number

7

DI Record Publish Date

August 02, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 1027