Sterile Spine Pedicle Screw System - Feeler Probe, Straight, Malleable - WISHBONE MEDICAL, INC.

Duns Number:062355158

Device Description: Feeler Probe, Straight, Malleable

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More Product Details

Catalog Number

62-2672-41

Brand Name

Sterile Spine Pedicle Screw System

Version/Model Number

62-2672-41

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"

-

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

-

Product Code Details

Product Code

HXB

Product Code Name

Probe

Device Record Status

Public Device Record Key

ca9acf70-8440-466a-bac4-e4e1faa5635e

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WISHBONE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 142
2 A medical device with a moderate to high risk that requires special controls. 1453