TRI - TRI Dental Implants Int. AG

Duns Number:485821164

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More Product Details

Catalog Number

TV37M10

Brand Name

TRI

Version/Model Number

B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

003a0249-e425-4aaf-a33c-cf736c765d6e

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRI DENTAL IMPLANTS INT. AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 334