N/A - Blunt Tip Laparoscopic Sealer/Divider - STRYKER SUSTAINABILITY SOLUTIONS, INC.

Duns Number:020198912

Device Description: Blunt Tip Laparoscopic Sealer/Divider

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More Product Details

Catalog Number

LF1637

Brand Name

N/A

Version/Model Number

N/A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 02, 2020

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"

Yes

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

NUJ

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

Device Record Status

Public Device Record Key

02ee3763-8a90-4616-9236-15d029d13b29

Public Version Date

July 02, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

50885825017625

Quantity per Package

6

Contains DI Package

00885825017620

Package Discontinue Date

July 02, 2020

Package Status

Not in Commercial Distribution

Package Type

case

"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