maxill Safeguard Paper Sterilization Wrap - 24" x 24" Crepe Paper - MAXILL, INC.

Duns Number:079343581

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More Product Details

Catalog Number

-

Brand Name

maxill Safeguard Paper Sterilization Wrap - 24" x 24" Crepe Paper

Version/Model Number

60163

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

-

Product Code Details

Product Code

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

8784cbe3-042d-4d41-844d-c950b4e485b9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 19, 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