KHEIRON - Connector holder - S.M.A.I.O

Duns Number:260585710

Device Description: Connector holder

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More Product Details

Catalog Number

01HC2050

Brand Name

KHEIRON

Version/Model Number

01HC2050

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

999e8bce-e8d3-4a1f-8446-f0bda1a4fd4f

Public Version Date

April 21, 2021

Public Version Number

2

DI Record Publish Date

December 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"S.M.A.I.O" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 115
2 A medical device with a moderate to high risk that requires special controls. 244