Propper Steri-Wrap® Unite™ 24" x 24" Sterilization Wrap - Propper Steri-Wrap® Unite™ 24" x 24" - PROPPER MANUFACTURING COMPANY, INC.

Duns Number:001483130

Device Description: Propper Steri-Wrap® Unite™ 24" x 24" Sterilization Wrap

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More Product Details

Catalog Number

31502400

Brand Name

Propper Steri-Wrap® Unite™ 24" x 24" Sterilization Wrap

Version/Model Number

31502400

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

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

8b039f35-4f28-497f-9565-ad57d2be5e17

Public Version Date

September 13, 2021

Public Version Number

1

DI Record Publish Date

September 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROPPER MANUFACTURING COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 49