AccuPlate® Patient-Specific Plate - MANDIBLE, 2.0 HEMI - Medcad

Duns Number:144723868

Device Description: MANDIBLE, 2.0 HEMI

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More Product Details

Catalog Number

ZB-PLT002

Brand Name

AccuPlate® Patient-Specific Plate

Version/Model Number

ZB-PLT002

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

K193280

Product Code Details

Product Code

JEY

Product Code Name

Plate, Bone

Device Record Status

Public Device Record Key

012d1848-b0a5-4101-9e99-d70c5588ac8b

Public Version Date

May 13, 2022

Public Version Number

1

DI Record Publish Date

May 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDCAD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 103