Screw Driver for Ratchet - SEWON MEDIX Screw Driver for Ratchet, Hex 1.28, - sewon medix Inc.

Duns Number:688731065

Device Description: SEWON MEDIX Screw Driver for Ratchet, Hex 1.28, Middle

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More Product Details

Catalog Number

RHD128M

Brand Name

Screw Driver for Ratchet

Version/Model Number

RHD128M

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

744e9c70-b9e4-4048-bc10-9ef124d94a79

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEWON MEDIX INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 185