Home GUDID 10846832011749 Phantom Fiber™ Suture
Primary DI 10846832011749
Brand Phantom Fiber™ Suture
Company TORNIER, INC.
Model SMSB0132
Published 2015-10-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NWJ Suture, recombinant technology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NWJ Suture, Recombinant Technology General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10846832011749 Package GS1 10 Not in Commercial Distribution 00846832011742 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10846832011749 10846832011749 00846832011742 00846832011742 846832011742 0846832011742
GMDN Terms# Term, Definition table Term Definition Polyhydroxybutyrate suture A sterile, single-strand (monofilament), synthetic, bioabsorbable thread derived from poly-4-hydroxybutyrate [a material isolated from prokaryotic cells using recombinant deoxyribonucleic acid (DNA) technology] intended to join (approximate) the edges of a soft-tissue wound or incision by stitching, or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Length 91 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 968990812 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00846832085675 TORNIER PERFORM™ REVERSED DWJ1017304 DWJ1017304 2022-01-05 00846832085682 TORNIER PERFORM™ REVERSED DWJ1017305 DWJ1017305 2022-01-05 00846832085699 TORNIER PERFORM™ REVERSED DWJ1017306 DWJ1017306 2022-01-05 00846832085705 TORNIER PERFORM™ REVERSED DWJ1017307 DWJ1017307 2022-01-05 00846832085743 TORNIER PERFORM™ REVERSED DWJ1017204 DWJ1017204 2022-01-05 00846832085750 TORNIER PERFORM™ REVERSED DWJ1017205 DWJ1017205 2022-01-05 00846832085767 TORNIER PERFORM™ REVERSED DWJ1017206 DWJ1017206 2022-01-05 00846832085774 TORNIER PERFORM™ REVERSED DWJ1017207 DWJ1017207 2022-01-05 00846832085781 TORNIER PERFORM™ REVERSED DWJ1017701 DWJ1017701 2022-01-05 00846832085798 TORNIER PERFORM™ REVERSED DWJ1017702 DWJ1017702 2022-01-05 00846832085804 TORNIER PERFORM™ REVERSED DWJ1017703 DWJ1017703 2022-01-05 00846832085811 TORNIER PERFORM™ REVERSED DWJ1017601 DWJ1017601 2022-01-05 00846832085828 TORNIER PERFORM™ REVERSED DWJ1017602 DWJ1017602 2022-01-05 00846832085835 TORNIER PERFORM™ REVERSED DWJ1017603 DWJ1017603 2022-01-05 00846832092086 Tornier Perform® Reversed Augmented Glenoid DWJ513 DWJ513 2022-05-10 00846832092093 Tornier Perform® Reversed Augmented Glenoid DWJ503 DWJ503 2022-05-10 00846832092109 Tornier Perform® Reversed Augmented Glenoid DWJ505 DWJ505 2022-05-10 00846832092123 Tornier Perform® Reversed Augmented Glenoid DWJ502 DWJ502 2022-05-10 00846832092130 Tornier Perform® Reversed Augmented Glenoid DWJ514 DWJ514 2022-05-10 00846832092147 Tornier Perform® Reversed Augmented Glenoid DWJ515 DWJ515 2022-05-10
Other Devices Sharing Product Codes# 
tornier.com