SGM-I - NAKANISHI INC.

Duns Number:690710546

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More Product Details

Catalog Number

-

Brand Name

SGM-I

Version/Model Number

SGM-I

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

KMW

Product Code Name

HANDPIECE, ROTARY BONE CUTTING

Device Record Status

Public Device Record Key

29713a45-19c8-49c9-827b-111b6e93a25d

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NAKANISHI INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 530
2 A medical device with a moderate to high risk that requires special controls. 757