GFS II 10702

GUDID 00816342021692

GFS II Large 12mm Loop

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342021692
NIH Device Record Key680f0411-a518-45b2-a7d0-5a807e13b7fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameGFS II
Version Model Number10702
Catalog Number10702
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

Customer Support Contacts

Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com
Phone941-755-7965
EmailParcusCS@Anika.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100816342021692 [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 Date2021-08-16
Device Publish Date2021-08-06

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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)

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