AccuModel® - ANATOMICAL MODEL, RIB, SINGLE - Medcad

Duns Number:144723868

Device Description: ANATOMICAL MODEL, RIB, SINGLE

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More Product Details

Catalog Number

ZB-3D208

Brand Name

AccuModel®

Version/Model Number

ZB-3D208

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

-

Product Code Details

Product Code

DZJ

Product Code Name

Driver, Wire, And Bone Drill, Manual

Device Record Status

Public Device Record Key

ad4dd709-ad21-49cd-855d-c19987d2bda9

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 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