BioHorizons - CGS Drill, 2.5 x 24mm, Single Use - BIOHORIZONS IMPLANT SYSTEMS, INC

Duns Number:967279910

Device Description: CGS Drill, 2.5 x 24mm, Single Use

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More Product Details

Catalog Number

-

Brand Name

BioHorizons

Version/Model Number

CGS-2524SU

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

c832d292-06fb-41ab-a9c1-5818dd17c076

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

August 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOHORIZONS IMPLANT SYSTEMS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 569
2 A medical device with a moderate to high risk that requires special controls. 982