InterActive® Implant Open-Tray Transfer - IMPLANT DIRECT SYBRON MANUFACTURING LLC

Duns Number:868856969

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More Product Details

Catalog Number

6534-08

Brand Name

InterActive® Implant Open-Tray Transfer

Version/Model Number

6534-08

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

f182bfc7-0b86-47a0-afe7-6cbda2059527

Public Version Date

December 07, 2018

Public Version Number

3

DI Record Publish Date

December 29, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPLANT DIRECT SYBRON MANUFACTURING LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 1817
U Unclassified 6