ROMEO 2 INSTRUMENTATION - Rod template L100 - SpineArt SA

Duns Number:483016148

Device Description: Rod template L100

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More Product Details

Catalog Number

ELL-IN 10 28-N

Brand Name

ROMEO 2 INSTRUMENTATION

Version/Model Number

ELL-IN 10 28-N

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

e9d082ff-a9a0-4db3-a6b3-3988f246e24a

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

October 27, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINEART SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 974
2 A medical device with a moderate to high risk that requires special controls. 5209