Catalog Number

P1340889

Brand Name

BIA310 Implant 4mm with 8mm abutment

Version/Model Number

P1340889

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K182116

Product Code

MAH

Product Code Name

Hearing aid, bone conduction, implanted

Public Device Record Key

93af2b52-e96c-487c-877d-1f038a73e255

Public Version Date

September 14, 2021

Public Version Number

2

DI Record Publish Date

May 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-