HANA ANTERIOR HIP UPPER STERILE DRAPE - MIZUHO ORTHOPEDIC SYSTEMS, INC.

Duns Number:084527241

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More Product Details

Catalog Number

-

Brand Name

HANA ANTERIOR HIP UPPER STERILE DRAPE

Version/Model Number

6855AUD-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

PUI

Product Code Name

Drape, Surgical, Exempt

Device Record Status

Public Device Record Key

6d3e12e9-de14-4cec-a094-dc9a868c196a

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Additional Identifiers

Package DI Number

10842430108867

Quantity per Package

6

Contains DI Package

00842430108860

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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