ROMEO 2 INSTRUMENTATION - FINE PITCH RATCHETING T-HANDLE - SpineArt SA

Duns Number:483016148

Device Description: FINE PITCH RATCHETING T-HANDLE

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More Product Details

Catalog Number

HAN-SI RF TE-N

Brand Name

ROMEO 2 INSTRUMENTATION

Version/Model Number

HAN-SI RF TE-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

f787ef34-6f45-4808-8483-6617e29a33fb

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 20, 2018

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