STRAP, POSITIONING - MIZUHO ORTHOPEDIC SYSTEMS, INC.

Duns Number:084527241

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More Product Details

Catalog Number

6988STP-12

Brand Name

STRAP, POSITIONING

Version/Model Number

6988STP-12

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"

-

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

FMQ

Product Code Name

Restraint, Protective

Device Record Status

Public Device Record Key

fd6ea2c1-1f1e-4bee-a889-7938e78ae476

Public Version Date

March 02, 2021

Public Version Number

1

DI Record Publish Date

February 22, 2021

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