Kyocera Medical Technologies, Inc. - 7mm Mini Washer, 316SS - KYOCERA MEDICAL TECHNOLOGIES, INC.

Duns Number:116995646

Device Description: 7mm Mini Washer, 316SS

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More Product Details

Catalog Number

1703-007-034

Brand Name

Kyocera Medical Technologies, Inc.

Version/Model Number

T 700

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

K113084

Product Code Details

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Device Record Status

Public Device Record Key

c775fa1e-9250-4227-8c0e-355441619f93

Public Version Date

July 29, 2019

Public Version Number

3

DI Record Publish Date

January 17, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KYOCERA MEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2246
2 A medical device with a moderate to high risk that requires special controls. 3237