10042

GUDID 00816342020374

PEEK CF Interference Screw Driver

PARCUS MEDICAL LLC

Surgical screwdriver, reusable
Primary Device ID00816342020374
NIH Device Record Key8259b3d3-8fc6-42e2-9b80-053199b31d31
Commercial Distribution StatusIn Commercial Distribution
Version Model Number10042
Catalog Number10042
Company DUNS859961950
Company NamePARCUS MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS100816342020374 [Primary]

FDA Product Code

HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816342020374]

Moist Heat or Steam Sterilization


[00816342020374]

Moist Heat or Steam Sterilization


[00816342020374]

Moist Heat or Steam Sterilization


[00816342020374]

Moist Heat or Steam Sterilization


[00816342020374]

Moist Heat or Steam Sterilization


[00816342020374]

Moist Heat or Steam Sterilization


[00816342020374]

Moist Heat or Steam Sterilization


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

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00816342025447 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025454 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025461 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
00816342025478 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
00816342025485 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
00816342025492 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
00816342025508 - X-Twist Biocomposite2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm

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