Angled Leg Cast Elevator - Angled Leg Cast Elevator 10" X 13" X 11" - GENEVA HEALTHCARE, LLC

Duns Number:964459106

Device Description: Angled Leg Cast Elevator 10" X 13" X 11"

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More Product Details

Catalog Number

503

Brand Name

Angled Leg Cast Elevator

Version/Model Number

503

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

2aff04d2-f6bd-4816-9079-a36ff1419b00

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Additional Identifiers

Package DI Number

10810044960997

Quantity per Package

2

Contains DI Package

00810044960990

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