Tools - Ratchet Hex Driver for Implant - A.B. DENTAL DEVICES LTD

Duns Number:534128491

Device Description: Ratchet Hex Driver for Implant

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More Product Details

Catalog Number

T3-2.4,15

Brand Name

Tools

Version/Model Number

T3-2.4,15

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)

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

463b45db-36c6-442e-93b7-1250339a28ee

Public Version Date

October 15, 2019

Public Version Number

1

DI Record Publish Date

October 07, 2019

Additional Identifiers

Package DI Number

17290111274241

Quantity per Package

10

Contains DI Package

07290111274244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag

"A.B. DENTAL DEVICES LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 190
2 A medical device with a moderate to high risk that requires special controls. 276