PKIT HANA DISTRACTION PAD BASIC TRC - MIZUHO ORTHOPEDIC SYSTEMS, INC.

Duns Number:084527241

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More Product Details

Catalog Number

6855DPB-5

Brand Name

PKIT HANA DISTRACTION PAD BASIC TRC

Version/Model Number

6855DPB-1

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)

-

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

9559cacd-a1de-4094-b2b2-69189ea74894

Public Version Date

May 04, 2021

Public Version Number

1

DI Record Publish Date

April 26, 2021

Additional Identifiers

Package DI Number

10842430115391

Quantity per Package

5

Contains DI Package

00842430115394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"MIZUHO ORTHOPEDIC SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1076
2 A medical device with a moderate to high risk that requires special controls. 44