Karl Schumacher Composite Putty - Regenerative Collagen Dental Bone Graft Composite - KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.

Duns Number:043957315

Device Description: Regenerative Collagen Dental Bone Graft Composite

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More Product Details

Catalog Number

-

Brand Name

Karl Schumacher Composite Putty

Version/Model Number

RCBP0100

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

LYC

Product Code Name

Bone Grafting Material, Synthetic

Device Record Status

Public Device Record Key

acc77152-cfe7-4245-9754-8965d84ef89e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 26, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KARL SCHUMACHER DENTAL INSTRUMENT CO., INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20