EMERGE MEDICAL & Design - 2.0MM DRILL BIT/JC/85MM - EMERGE MEDICAL, INC.

Duns Number:078642955

Device Description: 2.0MM DRILL BIT/JC/85MM

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More Product Details

Catalog Number

310.20.EM

Brand Name

EMERGE MEDICAL & Design

Version/Model Number

310.20.EM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2018

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

-

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

ef4eff12-8d8d-4a35-9525-3a49f1b18f8c

Public Version Date

November 22, 2018

Public Version Number

5

DI Record Publish Date

July 08, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EMERGE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 288
2 A medical device with a moderate to high risk that requires special controls. 1273