N/A - Blunt Tip Laparoscopic Sealer/Divider Without - STRYKER SUSTAINABILITY SOLUTIONS, INC.

Duns Number:020198912

Device Description: Blunt Tip Laparoscopic Sealer/Divider Without Nano-coating

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More Product Details

Catalog Number

LF1837

Brand Name

N/A

Version/Model Number

LF1837

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"

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

K172856,K172856

Product Code Details

Product Code

NUJ

Product Code Name

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

Device Record Status

Public Device Record Key

45a4eaa1-917f-4b83-b342-7d90e16b01f3

Public Version Date

August 06, 2019

Public Version Number

2

DI Record Publish Date

July 16, 2019

Additional Identifiers

Package DI Number

57613327500849

Quantity per Package

6

Contains DI Package

07613327500844

Package Discontinue Date

-

Package Status

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