FlexiGRAFT® - Connect Pre-Sutured Tendon (5x180 MM) - LIFENET HEALTH

Duns Number:121828156

Device Description: Connect Pre-Sutured Tendon (5x180 MM)

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More Product Details

Catalog Number

FCON

Brand Name

FlexiGRAFT®

Version/Model Number

FCON50180

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)

Yes

FDA Premarket Submission

-

Product Code Details

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Device Record Status

Public Device Record Key

a013939a-1a11-47ee-b265-d9f873a59b07

Public Version Date

August 31, 2021

Public Version Number

2

DI Record Publish Date

August 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFENET HEALTH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 1471