KISSloc® - KISSloc, Arrow, I K - ARTHROSURFACE INCORPORATED

Duns Number:144666109

Device Description: KISSloc, Arrow, I K

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More Product Details

Catalog Number

9V00-0200

Brand Name

KISSloc®

Version/Model Number

9V00-0200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K133835

Product Code Details

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Device Record Status

Public Device Record Key

e7409a8f-5560-45c5-aab3-1e20aca8dbb6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARTHROSURFACE INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 382
U Unclassified 7