"maxill steri-sox Self Sealing Sterilization Pouches 12" x 17.5" - MAXILL, INC.

Duns Number:079343581

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More Product Details

Catalog Number

-

Brand Name

"maxill steri-sox Self Sealing Sterilization Pouches 12" x 17.5"

Version/Model Number

60146

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102158,K102158

Product Code Details

Product Code

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

d43ebb94-6c9e-472d-96e6-dba13c5286cc

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

October 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAXILL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208
2 A medical device with a moderate to high risk that requires special controls. 61