Cutting Guide, 7mm - Cutting Guide, 7mm - AVANTI ORTHOPAEDICS LLC

Duns Number:043505370

Device Description: Cutting Guide, 7mm

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More Product Details

Catalog Number

-

Brand Name

Cutting Guide, 7mm

Version/Model Number

CG07

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

K211592

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

8a0f096e-fc54-4ff8-bf2e-39f625383a04

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVANTI ORTHOPAEDICS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 181