Baolai - Nanning Baolai medical instrument Co.,Ltd

Duns Number:544921355

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More Product Details

Catalog Number

-

Brand Name

Baolai

Version/Model Number

K10

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140233

Product Code Details

Product Code

ELC

Product Code Name

Scaler, Ultrasonic

Device Record Status

Public Device Record Key

14c5103c-73a6-4200-9e17-a13a3f5f6dbb

Public Version Date

March 11, 2022

Public Version Number

1

DI Record Publish Date

March 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NANNING BAOLAI MEDICAL INSTRUMENT 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. 46