Burkhart Autoclave Indicator Tape 1/2" (60yrds) - BURKHART DENTAL SUPPLY CO., THE

Duns Number:027532357

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More Product Details

Catalog Number

-

Brand Name

Burkhart Autoclave Indicator Tape 1/2" (60yrds)

Version/Model Number

72720796

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)

-

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

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Device Record Status

Public Device Record Key

66ab49df-5748-46f0-bb0d-cfb3f9baff96

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

10854212006513

Quantity per Package

36

Contains DI Package

00854212006516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BURKHART DENTAL SUPPLY CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 214
2 A medical device with a moderate to high risk that requires special controls. 43