Bhi Screw removal kit – Damaged screw head retriever Drill 2.0mm - Bhi Screw removal kit – Damaged screw head - BHI IMPLANTS LTD

Duns Number:600330916

Device Description: Bhi Screw removal kit – Damaged screw head retriever Drill 2.0mm

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More Product Details

Catalog Number

BH-TBD200

Brand Name

Bhi Screw removal kit – Damaged screw head retriever Drill 2.0mm

Version/Model Number

1

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

1f0b8f56-8ba3-4c42-9ca2-966cd0f0a81b

Public Version Date

February 04, 2020

Public Version Number

1

DI Record Publish Date

January 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BHI IMPLANTS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 124
2 A medical device with a moderate to high risk that requires special controls. 353