Hobbs Medical Grasping Forceps - A flexible manual device intended to be used in - HOBBS MEDICAL, INC.

Duns Number:076769355

Device Description: A flexible manual device intended to be used in combination with a compatible endoscope to A flexible manual device intended to be used in combination with a compatible endoscope to grasp foreign bodies. It is constructed of a flexible metal coil and plastic tube whose distal end is equipped with grasping tongs which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reuseable device.

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More Product Details

Catalog Number

5004

Brand Name

Hobbs Medical Grasping Forceps

Version/Model Number

5004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K833125

Product Code Details

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Device Record Status

Public Device Record Key

9899bed2-7ce9-41e0-99b5-b0ce712afd93

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOBBS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 196