Arm Board Straps - Arm Board Strap 32" X 1.5" - GENEVA HEALTHCARE, LLC

Duns Number:964459106

Device Description: Arm Board Strap 32" X 1.5"

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More Product Details

Catalog Number

40-700-00

Brand Name

Arm Board Straps

Version/Model Number

40-700-00

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

4de3c9e5-f82a-4c6b-9a29-4078b5ae9934

Public Version Date

July 15, 2020

Public Version Number

2

DI Record Publish Date

February 28, 2020

Additional Identifiers

Package DI Number

00810044960594

Quantity per Package

50

Contains DI Package

10810044960591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"GENEVA HEALTHCARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 148