FLEXIBLE - Microport Orthopedics Inc.

Duns Number:079118736

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More Product Details

Catalog Number

1811R145

Brand Name

FLEXIBLE

Version/Model Number

1811R145

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

HWE

Product Code Name

INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Device Record Status

Public Device Record Key

c9ddd858-d336-48da-b28d-f005d9a8b839

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICROPORT ORTHOPEDICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7823
2 A medical device with a moderate to high risk that requires special controls. 12222
3 A medical device with high risk that requires premarket approval 109