GEL PAD, NERVE, ULNAR/BRACHIAL, RECTANG - MIZUHO ORTHOPEDIC SYSTEMS, INC.

Duns Number:084527241

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More Product Details

Catalog Number

10306

Brand Name

GEL PAD, NERVE, ULNAR/BRACHIAL, RECTANG

Version/Model Number

10306

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

-

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

FMP

Product Code Name

Protector, Skin Pressure

Device Record Status

Public Device Record Key

935f2260-ecba-4659-9206-dee07e9dec94

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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