Prophecy - PROPHECY® ALIGNMENT GUIDES - Microport Orthopedics Inc.

Duns Number:079118736

Device Description: PROPHECY® ALIGNMENT GUIDES

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More Product Details

Catalog Number

PNV10045

Brand Name

Prophecy

Version/Model Number

PNV10045

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 22, 2027

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)

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

JWH

Product Code Name

PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Device Record Status

Public Device Record Key

3242fef5-b0e9-4c37-9ed4-49c7c6388031

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

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