DS Prime Taper - PrimeTaper Surgical Tray GS Medium - Dentsply Implants Manufacturing GmbH

Duns Number:344038836

Device Description: PrimeTaper Surgical Tray GS Medium

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More Product Details

Catalog Number

68017268

Brand Name

DS Prime Taper

Version/Model Number

68017268

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

-

Prescription Use (Rx)

-

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

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Device Record Status

Public Device Record Key

3a363ccd-b9fd-4507-82f6-592aebfe94a8

Public Version Date

May 31, 2022

Public Version Number

1

DI Record Publish Date

May 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY IMPLANTS MANUFACTURING GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1379
2 A medical device with a moderate to high risk that requires special controls. 2266