SURFIX® - The drilling guide is placed in the plate on the - NEWDEAL

Duns Number:536935331

Device Description: The drilling guide is placed in the plate on the bone and is used to guide the drilling of The drilling guide is placed in the plate on the bone and is used to guide the drilling of the bone and protect the soft tissues.

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More Product Details

Catalog Number

-

Brand Name

SURFIX®

Version/Model Number

MA006ND

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"

Yes

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

HTW

Product Code Name

BIT, DRILL

Device Record Status

Public Device Record Key

e641f784-108d-4536-8bba-333e2ae7488e

Public Version Date

April 06, 2020

Public Version Number

5

DI Record Publish Date

May 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEWDEAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 388
2 A medical device with a moderate to high risk that requires special controls. 235