STOP FOR CYLINDRICAL DRILL - STOP FOR CYLINDRICAL DRILL D. 3.00 H.8.5 MM - SWEDEN & MARTINA SPA

Duns Number:433815198

Device Description: STOP FOR CYLINDRICAL DRILL D. 3.00 H.8.5 MM

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More Product Details

Catalog Number

STOP3-300-085

Brand Name

STOP FOR CYLINDRICAL DRILL

Version/Model Number

STOP3-300-085

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

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

74e0f8af-e637-4da8-afdd-ca5ab76909a3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SWEDEN & MARTINA SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1248
2 A medical device with a moderate to high risk that requires special controls. 1062