Hobbs Posi-Stop Injection Needle - A flexible, sterile, sharp bevel-edged, hollow - HOBBS MEDICAL, INC.

Duns Number:076769355

Device Description: A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-oper A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

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More Product Details

Catalog Number

4712S-01

Brand Name

Hobbs Posi-Stop Injection Needle

Version/Model Number

4712S-01

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

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

K834403

Product Code Details

Product Code

FBK

Product Code Name

Endoscopic Injection Needle, Gastroenterology-Urology

Device Record Status

Public Device Record Key

e17cdae1-f43d-49b4-be29-eff9b7e19de8

Public Version Date

July 06, 2018

Public Version Number

3

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