Stryker Universal Select Sterilization Tray System - 1/4 DIN Instrument/Accessory Tray - PARAGON MEDICAL, INC.

Duns Number:609244454

Device Description: 1/4 DIN Instrument/Accessory Tray

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More Product Details

Catalog Number

-

Brand Name

Stryker Universal Select Sterilization Tray System

Version/Model Number

29-13920

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

-

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

c5d01641-8eb9-498e-bdcb-1d215483cf37

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

April 25, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARAGON MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 50