MaxFuse PEEK VBR SYSTEM - MAXFUSE,14.5x17x5356 REPLICA TRL SPACER - Rti Surgical, Inc.

Duns Number:117560455

Device Description: MAXFUSE,14.5x17x5356 REPLICA TRL SPACER

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More Product Details

Catalog Number

725-157

Brand Name

MaxFuse PEEK VBR SYSTEM

Version/Model Number

725-157

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

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

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

7a8c6967-ae7a-4003-8d9d-a1d8a946e38a

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

February 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RTI SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 681
2 A medical device with a moderate to high risk that requires special controls. 1571