Reform POCT System - Ø4.5mm Duckbill Probe, Straight - PRECISION SPINE, INC.

Duns Number:079398589

Device Description: Ø4.5mm Duckbill Probe, Straight

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More Product Details

Catalog Number

55-IN-0023

Brand Name

Reform POCT System

Version/Model Number

55-IN-0023

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)

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

HXB

Product Code Name

Probe

Device Record Status

Public Device Record Key

7fbef399-b5d8-4fb2-8e48-937b8ed921fa

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRECISION SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1423
2 A medical device with a moderate to high risk that requires special controls. 4960
U Unclassified 26