ReLine - RELINE C Holder, Rod-Rod Connector - Nuvasive, Inc.

Duns Number:053950783

Device Description: RELINE C Holder, Rod-Rod Connector

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

ReLine

Version/Model Number

3990035

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

98a083f9-c1f4-4204-a1f1-8cac17819426

Public Version Date

September 01, 2022

Public Version Number

1

DI Record Publish Date

August 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUVASIVE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4207
2 A medical device with a moderate to high risk that requires special controls. 38751
3 A medical device with high risk that requires premarket approval 84
U Unclassified 29