Curved Osteotome - Curved Osteotome 1/2" - SIGNAL MEDICAL CORPORATION

Duns Number:169289308

Device Description: Curved Osteotome 1/2"

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More Product Details

Catalog Number

BIO-1-1095

Brand Name

Curved Osteotome

Version/Model Number

1/2"

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

-

Prescription Use (Rx)

-

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

GFI

Product Code Name

Osteotome, Manual

Device Record Status

Public Device Record Key

41a7d260-641e-46a0-b1b4-2f421ea323ec

Public Version Date

August 19, 2021

Public Version Number

1

DI Record Publish Date

August 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIGNAL MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 233