XTCERA - 30ml - DONGGUAN XIANGTONG CO.,LTD

Duns Number:544441227

Device Description: 30ml

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More Product Details

Catalog Number

-

Brand Name

XTCERA

Version/Model Number

D3

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

K220017

Product Code Details

Product Code

EIH

Product Code Name

Powder, Porcelain

Device Record Status

Public Device Record Key

5c9b18f5-bd7f-4cc4-af4c-3889427b0808

Public Version Date

September 23, 2022

Public Version Number

1

DI Record Publish Date

September 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DONGGUAN XIANGTONG CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 178