WishBox - Solid T15 Screwdriver - WISHBONE MEDICAL, INC.

Duns Number:062355158

Device Description: Solid T15 Screwdriver

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More Product Details

Catalog Number

-

Brand Name

WishBox

Version/Model Number

SDRASS15

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

-

Product Code Details

Product Code

HXX

Product Code Name

Screwdriver

Device Record Status

Public Device Record Key

0912df41-19c3-4bf2-a59a-92edf13ac765

Public Version Date

September 09, 2021

Public Version Number

2

DI Record Publish Date

June 30, 2021

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