SHINING 3D® - Shining 3D Tech Co., Ltd.

Duns Number:529835314

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More Product Details

Catalog Number

-

Brand Name

SHINING 3D®

Version/Model Number

Surgical Guide Resin SG01

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

Yes

Prescription Use (Rx)

-

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

OFY

Product Code Name

Dental Implant Surgical Tray

Device Record Status

Public Device Record Key

688748fc-4a9f-4ea9-9964-d39b4de74c9f

Public Version Date

July 20, 2022

Public Version Number

2

DI Record Publish Date

July 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHINING 3D TECH CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 18