JULIET ® INSTRUMENTATION - BAYONETED BLADE HOLDER - SpineArt SA

Duns Number:483016148

Device Description: BAYONETED BLADE HOLDER

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More Product Details

Catalog Number

JLL-IN 00 03-N

Brand Name

JULIET ® INSTRUMENTATION

Version/Model Number

JLL-IN 00 03-N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 14, 2019

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

GDI

Product Code Name

Dissector, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

153efd64-5d74-4818-a05d-15127affb6d0

Public Version Date

February 14, 2019

Public Version Number

1

DI Record Publish Date

January 14, 2019

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