10019

GUDID 00816342020169

12x30mm Titanium Interference Screw with 1.5mm cannulation

PARCUS MEDICAL LLC

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00816342020169
NIH Device Record Key72634312-b8e9-42de-90fc-cd628c90a649
Commercial Distribution StatusIn Commercial Distribution
Version Model Number10019
Catalog Number10019
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
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
Phone941-755-7965
EmailParcusCS@Anika.com

Device Dimensions

Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter
Outer Diameter12 Millimeter
Length30 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816342020169 [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 Date2021-12-15
Device Publish Date2021-12-07

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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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