AIMGEN MAX - AIMGEN MAX Implant System Φ3.5/L8.0 - Achimhai Medical Corporation

Duns Number:694197900

Device Description: AIMGEN MAX Implant System Φ3.5/L8.0

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More Product Details

Catalog Number

PFX-3908SS-C

Brand Name

AIMGEN MAX

Version/Model Number

PFX-3908SS

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

K172630

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

4f7ade19-20c9-4220-9337-c1b603e9d60e

Public Version Date

December 02, 2021

Public Version Number

1

DI Record Publish Date

November 24, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACHIMHAI MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 1228