Bone Carrier - Bone carrier is used during surgery to hold Bone - Suncoast Dental, Inc

Duns Number:078352849

Device Description: Bone carrier is used during surgery to hold Bone for grafting whilst the bone is being car Bone carrier is used during surgery to hold Bone for grafting whilst the bone is being carried to the oral cavity

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More Product Details

Catalog Number

Bone Carrier

Brand Name

Bone Carrier

Version/Model Number

Bone Carrier

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

DZN

Product Code Name

Instruments, Dental Hand

Device Record Status

Public Device Record Key

79da6c15-56b2-47c7-8dac-4364c7a4bda7

Public Version Date

February 11, 2021

Public Version Number

1

DI Record Publish Date

February 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNCOAST DENTAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 405
2 A medical device with a moderate to high risk that requires special controls. 536