KMC Working Channel, 10 Gauge - KMC Working Channel, 10 Gauge - Shanghai Kinetic Medical Co., Ltd.

Duns Number:528198569

Device Description: KMC Working Channel, 10 Gauge

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More Product Details

Catalog Number

-

Brand Name

KMC Working Channel, 10 Gauge

Version/Model Number

KMC-008-01

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113742

Product Code Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

f63f6515-0681-48df-86fc-3e0bfc95983b

Public Version Date

October 09, 2020

Public Version Number

1

DI Record Publish Date

October 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHANGHAI KINETIC MEDICAL CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 106