DSS™ Caliper, Adapter Fixation - Paradigm Spine GmbH

Duns Number:537619731

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More Product Details

Catalog Number

-

Brand Name

DSS™ Caliper, Adapter Fixation

Version/Model Number

DAT30430

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

KTZ

Product Code Name

Caliper

Device Record Status

Public Device Record Key

56294205-e1ed-4f27-af40-2c538d580f3f

Public Version Date

June 10, 2021

Public Version Number

4

DI Record Publish Date

June 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARADIGM SPINE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 191
2 A medical device with a moderate to high risk that requires special controls. 301
3 A medical device with high risk that requires premarket approval 49