OsteoMed - Bur Hole Plate, Small - OSTEOMED LLC

Duns Number:606417780

Device Description: Bur Hole Plate, Small

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More Product Details

Catalog Number

218-0067

Brand Name

OsteoMed

Version/Model Number

218-0067

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

-

Product Code Details

Product Code

GXR

Product Code Name

COVER, BURR HOLE

Device Record Status

Public Device Record Key

6be04d19-9eaa-42cf-b85e-a033f794f79e

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

August 14, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSTEOMED LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 95
2 A medical device with a moderate to high risk that requires special controls. 7762
U Unclassified 105