Integra® Miltex® - Wax, 10X Light Pink, 2.27kg (5 lb.) - INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Duns Number:081277700

Device Description: Wax, 10X Light Pink, 2.27kg (5 lb.)

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More Product Details

Catalog Number

195-55520

Brand Name

Integra® Miltex®

Version/Model Number

195-55520

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2022

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

EGD

Product Code Name

WAX, DENTAL, INTRAORAL

Device Record Status

Public Device Record Key

898bb97c-9dff-4840-a033-75fc9da5cb49

Public Version Date

August 03, 2022

Public Version Number

3

DI Record Publish Date

October 24, 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