CARDINAL HEALTH - 3.5mm T-Plate 3 Holes Head 5 Holes Shaft 75mm - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: 3.5mm T-Plate 3 Holes Head 5 Holes Shaft 75mm Oblique Angle Material: 316L Stainless Steel

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More Product Details

Catalog Number

P2A635-05

Brand Name

CARDINAL HEALTH

Version/Model Number

P2A635-05

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2018

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

Yes

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

-

Product Code Details

Product Code

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

d5ab5f87-1f13-46bf-b01d-c0ed08fef073

Public Version Date

July 23, 2018

Public Version Number

3

DI Record Publish Date

March 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40