Attest™ - 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge - 3M COMPANY

Duns Number:830016148

Device Description: 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack for 132°C 4-min and 135 degree C 3-min 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack for 132°C 4-min and 135 degree C 3-min Steam Sterilization, 24/Case 41482VF

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More Product Details

Catalog Number

41482VF

Brand Name

Attest™

Version/Model Number

41482VF

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

K121593,K121593

Product Code Details

Product Code

FRC

Product Code Name

Indicator, biological sterilization process

Device Record Status

Public Device Record Key

a6d60d59-1afc-42cf-80c6-f79c78ad09bd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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