Reliance Cervical IBF System - Cervical IBF-HA PEEK-STERILE, 14mm x 11mm x 4mm, - RELIANCE MEDICAL SYSTEMS, LLC

Duns Number:064885444

Device Description: Cervical IBF-HA PEEK-STERILE, 14mm x 11mm x 4mm, 0°, PEEK OPTIMA LT1-HA

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More Product Details

Catalog Number

1-02-004-HAG

Brand Name

Reliance Cervical IBF System

Version/Model Number

1-02-004-HAG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

Yes

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

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

3f230a50-d25b-4334-99b2-fe226c913e0b

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RELIANCE MEDICAL SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 641