3DP Lumbar Interbody System - 12in 2mm Pituitary Rongeur - Genesys Orthopedics Systems LLC

Duns Number:017921066

Device Description: 12in 2mm Pituitary Rongeur

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More Product Details

Catalog Number

GP532-2

Brand Name

3DP Lumbar Interbody System

Version/Model Number

1

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

K182987

Product Code Details

Product Code

HTX

Product Code Name

Rongeur

Device Record Status

Public Device Record Key

56a0f7e8-4b0f-4f27-9b25-413dbeea8f8c

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENESYS ORTHOPEDICS SYSTEMS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 4608