Achieve - Achieve Gold Tissue Marker, 14g x 11cm - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: Achieve Gold Tissue Marker, 14g x 11cm

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More Product Details

Catalog Number

M1411

Brand Name

Achieve

Version/Model Number

M1411

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

NEU

Product Code Name

Marker, Radiographic, Implantable

Device Record Status

Public Device Record Key

c3d05106-491d-4e9d-ab43-c6e389d11c97

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 12, 2017

Additional Identifiers

Package DI Number

50885403242340

Quantity per Package

5

Contains DI Package

10885403242342

Package Discontinue Date

-

Package Status

-

Package Type

Case

"CAREFUSION 2200, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8016
2 A medical device with a moderate to high risk that requires special controls. 6223