Implant Prosthetics - Nobel Active/Conical RP Engaging Verification - Implants and Attachments, Inc.

Duns Number:054875224

Device Description: Nobel Active/Conical RP Engaging Verification CylinderKit contains:1 Nobel Active/Conical Nobel Active/Conical RP Engaging Verification CylinderKit contains:1 Nobel Active/Conical RP Engaging Verification Cylinder (00842092125946)1 Nobel Active/Conical RP Guide Pin (00842092126066)1 Nobel Active/Conical RP Titanium Screw (00842092165805)

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More Product Details

Catalog Number

9000930

Brand Name

Implant Prosthetics

Version/Model Number

9000930

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

K183518,K183518

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

560b9060-0ba0-4b74-a031-e66a4fffaa19

Public Version Date

October 19, 2022

Public Version Number

2

DI Record Publish Date

September 06, 2022

Additional Identifiers

Package DI Number

00842092165836

Quantity per Package

10

Contains DI Package

00842092165829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"IMPLANTS AND ATTACHMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 958
2 A medical device with a moderate to high risk that requires special controls. 1846