GTC® - GTC Dental Tray (Small), 5/Set - INTEGRA LIFESCIENCES CORPORATION

Duns Number:963856096

Device Description: GTC Dental Tray (Small), 5/Set

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More Product Details

Catalog Number

-

Brand Name

GTC®

Version/Model Number

GTCDTSS

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

K962155,K962155

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Device Record Status

Public Device Record Key

76b8ece4-0af9-4584-8ad8-8add06e98a9f

Public Version Date

January 13, 2020

Public Version Number

4

DI Record Publish Date

July 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1079
2 A medical device with a moderate to high risk that requires special controls. 2066