Chromic Gut 3-0 18" C6 - Dental Health Products Inc

Duns Number:623191194

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More Product Details

Catalog Number

850-CG3018C6

Brand Name

Chromic Gut 3-0 18" C6

Version/Model Number

850-CG3018C6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

GAL

Product Code Name

Suture, Absorbable, Natural

Device Record Status

Public Device Record Key

3a9ad5dc-4464-4a01-8fc5-0d0795863a6c

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

January 24, 2017

Additional Identifiers

Package DI Number

D773850CG3018C62

Quantity per Package

12

Contains DI Package

D773850CG3018C61

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DENTAL HEALTH PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 464
2 A medical device with a moderate to high risk that requires special controls. 78