JAZZ System - IMPLANET

Duns Number:291993439

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More Product Details

Catalog Number

550402

Brand Name

JAZZ System

Version/Model Number

JAZZ CLAW – Instruments Container - Lid

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

-

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

OWI

Product Code Name

Bone Fixation Cerclage, Sublaminar

Device Record Status

Public Device Record Key

1e2b8bfd-b987-4dd3-b44c-1c22471e6be0

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

March 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPLANET" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 236
2 A medical device with a moderate to high risk that requires special controls. 828