IO-FLEX - IO-Flex Wire - SPINAL ELEMENTS

Duns Number:004022104

Device Description: IO-Flex Wire

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More Product Details

Catalog Number

-

Brand Name

IO-FLEX

Version/Model Number

iO-Wire

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113533

Product Code Details

Product Code

HAE

Product Code Name

Rongeur, Manual

Device Record Status

Public Device Record Key

2aa1e101-6954-4a7c-9934-0bd849ff8e62

Public Version Date

September 20, 2021

Public Version Number

5

DI Record Publish Date

June 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINAL ELEMENTS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1993
2 A medical device with a moderate to high risk that requires special controls. 3642
U Unclassified 15