GEN2 - CASPAR IVD, TEETH, 5X14MM, UP 7.25" - SURGIX MEDICAL LLC

Duns Number:080402644

Device Description: CASPAR IVD, TEETH, 5X14MM, UP 7.25"

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More Product Details

Catalog Number

G2N77867

Brand Name

GEN2

Version/Model Number

G2N77867

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)

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

HAE

Product Code Name

Rongeur, Manual

Device Record Status

Public Device Record Key

34136472-568c-438f-a07e-749e70f819fb

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SURGIX MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 738
2 A medical device with a moderate to high risk that requires special controls. 1804