Stryker - BALL PROBE, RIGHT BAYONET, 2MM, 7MM OFFSET - TEDAN SURGICAL INNOVATIONS, L.L.C.

Duns Number:791619393

Device Description: BALL PROBE, RIGHT BAYONET, 2MM, 7MM OFFSET

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More Product Details

Catalog Number

-

Brand Name

Stryker

Version/Model Number

48252501

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HXB

Product Code Name

Probe

Device Record Status

Public Device Record Key

9850071f-3e54-4565-93d6-909c923f6d95

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEDAN SURGICAL INNOVATIONS, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2398
2 A medical device with a moderate to high risk that requires special controls. 51