Fortilink-C IBF System - Trial Spacer - Pioneer Surgical Technology, Inc.

Duns Number:793384496

Device Description: Trial Spacer

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More Product Details

Catalog Number

65-C-TRL-L-8-6L

Brand Name

Fortilink-C IBF System

Version/Model Number

65-C-TRL-L-8-6L

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

8a8b8969-4a31-485d-9b23-d03a791fc6f5

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

March 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PIONEER SURGICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3116
2 A medical device with a moderate to high risk that requires special controls. 5221