10421

GUDID 00816342021333

5.5mm Slotted Tendon Harvester

PARCUS MEDICAL LLC

Tendon stripper

• Primary Device ID: 00816342021333
• NIH Device Record Key: 0b9cb08f-4dea-4b99-ae96-86527ee1b5b4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 10421
• Catalog Number: 10421
• 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	00816342021333 [Primary]

FDA Product Code

• HRT: Stripper, Surgical

Sterilization

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

[00816342021333]

Moist Heat or Steam Sterilization

[00816342021333]

Moist Heat or Steam Sterilization

[00816342021333]

Moist Heat or Steam Sterilization

[00816342021333]

Moist Heat or Steam Sterilization

[00816342021333]

Moist Heat or Steam Sterilization

[00816342021333]

Moist Heat or Steam Sterilization

[00816342021333]

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

• 00816342022491 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025447 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025454 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025461 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 4.75mm
• 00816342025478 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025485 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025492 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm
• 00816342025508 - X-Twist Biocomposite: 2025-05-07 X-Twist Biocomposite Suture Anchor 5.5mm