10505U

GUDID 00816342023597

Unsterile 3.2mm x 130mm Drill Bit

PARCUS MEDICAL LLC

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable

• Primary Device ID: 00816342023597
• NIH Device Record Key: 417bc275-6b25-4e38-8cf1-4f2596c4a722
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 10505U
• Catalog Number: 10505U
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com
• Phone: 941-755-7965
• Email: ParcusCS@Anika.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816342023597 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00816342023597]

Moist Heat or Steam Sterilization

[00816342023597]

Moist Heat or Steam Sterilization

[00816342023597]

Moist Heat or Steam Sterilization

[00816342023597]

Moist Heat or Steam Sterilization

[00816342023597]

Moist Heat or Steam Sterilization

[00816342023597]

Moist Heat or Steam Sterilization

[00816342023597]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-16
• Device Publish Date: 2021-08-06

Devices Manufactured by PARCUS MEDICAL LLC

• 00816342023573 - Parcus Instrumentation: 2023-08-07 10mm SLiK Fix Drill Bit
• 00816342023580 - Parcus Instrumentation: 2023-08-07 1.8mm Reusable Draw Tight Drill Bit with Stop
• 00816342023634 - Parcus Instrumentation: 2023-08-07 3.0mm x 100mm Reusable Drill Bit with Stop
• 00816342023658 - Parcus Instrumentation: 2023-08-07 28 Knotless Reusable Drill Bit
• 00816342023726 - Parcus Instrumentation: 2023-08-07 1.1mm x 400mm Nitinol Guide Wire
• 00816342023740 - Parcus Instrumentation: 2023-08-07 28 Knotless Reusable Drill Guide, Hip Length
• 00816342023795 - Knotless Push-In Suture Anchor: 2023-08-07 35 Knotless Push-In Suture Anchor with Driver
• 00816342023931 - Twist PEEK Suture Anchor: 2023-08-07 4.5mm Twist, screw-in, suture anchor, w/2 1.6mm suture tapes (wht/blu & wht/blk)