10314

GUDID 00816342021166

45 Knotless Push-In Suture Anchor

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342021166
NIH Device Record Key57e355bc-b0c1-4951-ae00-6dcf2d1ee5ac
Commercial Distribution StatusIn Commercial Distribution
Version Model Number10314
Catalog Number10314
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816342021166 [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

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)

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