N/A - Trocar Sleeve w/Stability Sleeve - STRYKER SUSTAINABILITY SOLUTIONS, INC.

Duns Number:020198912

Device Description: Trocar Sleeve w/Stability Sleeve

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More Product Details

Catalog Number

CB5ST

Brand Name

N/A

Version/Model Number

N/A

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)

Yes

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

NLM

Product Code Name

LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Device Record Status

Public Device Record Key

83c6eec3-9eb2-4ca1-8a88-eb18fbb35544

Public Version Date

November 16, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

30885825014538

Quantity per Package

6

Contains DI Package

00885825014537

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack

"STRYKER SUSTAINABILITY SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 304
2 A medical device with a moderate to high risk that requires special controls. 1702
U Unclassified 12