3M™ Attest™ - 3M™ Attest™ Steam Chemical Integrator Test Pack, - 3M COMPANY

Duns Number:830016148

Device Description: 3M™ Attest™ Steam Chemical Integrator Test Pack, 41360, 4 PK/BG 4 BG/BX 4 BX/CS

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More Product Details

Catalog Number

41360

Brand Name

3M™ Attest™

Version/Model Number

41360

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

K200766,K200766,K200766

Product Code Details

Product Code

FRC

Product Code Name

Indicator, biological sterilization process

Device Record Status

Public Device Record Key

5050b568-9cec-4d1f-9305-bf783a89eaba

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Additional Identifiers

Package DI Number

50707387787245

Quantity per Package

4

Contains DI Package

30707387787241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"3M COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 274
2 A medical device with a moderate to high risk that requires special controls. 444
U Unclassified 7