0 Deg 10mm Laparoscope Assembly POC - The POC endoscope is intended use for endoscopic - Poc

Duns Number:118244987

Device Description: The POC endoscope is intended use for endoscopic viewing of internal surgery sites during The POC endoscope is intended use for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with endoscopic instrument control systems during laparoscopic and thoracoscopic surgical procedures.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

0 Deg 10mm Laparoscope Assembly POC

Version/Model Number

6711-901

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

K914084

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

edb41f82-2daf-4782-bc5c-6d5b0a1ff3fe

Public Version Date

March 31, 2021

Public Version Number

1

DI Record Publish Date

March 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10