Integra® Miltex® - Scaler, Baylor 1-2, Double-Ended, Gold-White, - INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Duns Number:081277700

Device Description: Scaler, Baylor 1-2, Double-Ended, Gold-White, Tactile Tone™

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More Product Details

Catalog Number

TPBY12-DW

Brand Name

Integra® Miltex®

Version/Model Number

TPBY12-DW

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2020

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

EMN

Product Code Name

SCALER, PERIODONTIC

Device Record Status

Public Device Record Key

f0bc2bdc-1b68-4f0c-8193-2342fd689194

Public Version Date

October 28, 2020

Public Version Number

4

DI Record Publish Date

April 19, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES PRODUCTION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15051
2 A medical device with a moderate to high risk that requires special controls. 4286
3 A medical device with high risk that requires premarket approval 2
U Unclassified 3