G-CEM LinkForce™ - G-CEM LinkForce™ Starter Kit A2, 1 LinkForce - Gc America Inc.

Duns Number:005473608

Device Description: G-CEM LinkForce™ Starter Kit A2, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1

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More Product Details

Catalog Number

010118

Brand Name

G-CEM LinkForce™

Version/Model Number

010118

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

K153231,K153231

Product Code Details

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Device Record Status

Public Device Record Key

68c887f2-75e9-449c-81be-e2bc2608062b

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Additional Identifiers

Package DI Number

44548161321847

Quantity per Package

24

Contains DI Package

14548161321846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"GC AMERICA INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 480
2 A medical device with a moderate to high risk that requires special controls. 4772