ProChondrix® Instrument Set - Single-use disposable orthopedic manual surgical - DSM BIOMEDICAL, INC.

Duns Number:131107757

Device Description: Single-use disposable orthopedic manual surgical instrument set

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More Product Details

Catalog Number

-

Brand Name

ProChondrix® Instrument Set

Version/Model Number

58160-15

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 08, 2020

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

HTW

Product Code Name

Bit, Drill

Device Record Status

Public Device Record Key

766b9f0c-d376-4338-8523-f16997c33b3d

Public Version Date

June 09, 2020

Public Version Number

4

DI Record Publish Date

September 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DSM BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 132
U Unclassified 5