QUANTUM - IN2BONES

Duns Number:263616749

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More Product Details

Catalog Number

-

Brand Name

QUANTUM

Version/Model Number

M50 SU151

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191380

Product Code Details

Product Code

HSN

Product Code Name

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Device Record Status

Public Device Record Key

245edff5-f305-4d8c-a3b0-af046e18360d

Public Version Date

August 03, 2020

Public Version Number

1

DI Record Publish Date

July 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IN2BONES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 281
2 A medical device with a moderate to high risk that requires special controls. 608