Synd-EZ 11224

GUDID M685112240

Synd-EZ SS

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device IDM685112240
NIH Device Record Keycbb0699b-e2cc-4443-8000-996fed88c189
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynd-EZ
Version Model Number11224
Catalog Number11224
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Customer Support Contacts

Phone941-755-7965
EmailCustomerService@ParcusMedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM685112240 [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 Date2019-12-25
Device Publish Date2019-12-17

On-Brand Devices [Synd-EZ]

M685112240Synd-EZ SS
M685112230Synd-EZ Ti
00816342024402Synd-EZ Ti

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