Synd EZ

GUDID 00816342025003

Synd-EZ Solo Ti

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342025003
NIH Device Record Key78e823bd-6f16-446c-8a3a-139b926e0adc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynd EZ
Version Model Number11225
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816342025003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-07
Device Publish Date2023-07-30

Devices Manufactured by PARCUS MEDICAL LLC

00816342023573 - Parcus Instrumentation2023-08-07 10mm SLiK Fix Drill Bit
00816342023580 - Parcus Instrumentation2023-08-07 1.8mm Reusable Draw Tight Drill Bit with Stop
00816342023634 - Parcus Instrumentation2023-08-07 3.0mm x 100mm Reusable Drill Bit with Stop
00816342023658 - Parcus Instrumentation2023-08-07 28 Knotless Reusable Drill Bit
00816342023726 - Parcus Instrumentation2023-08-07 1.1mm x 400mm Nitinol Guide Wire
00816342023740 - Parcus Instrumentation2023-08-07 28 Knotless Reusable Drill Guide, Hip Length
00816342023795 - Knotless Push-In Suture Anchor2023-08-07 35 Knotless Push-In Suture Anchor with Driver
00816342023931 - Twist PEEK Suture Anchor2023-08-07 4.5mm Twist, screw-in, suture anchor, w/2 1.6mm suture tapes (wht/blu & wht/blk)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.