PANALOK 213025

GUDID 10886705002580

PANALOK Slotted Drill Guide Fishmouth

DEPUY MITEK, LLC

Manual surgical rotary handpiece, reusable

• Primary Device ID: 10886705002580
• NIH Device Record Key: c6e73e53-f311-4f01-9fc4-ecc8e832c9a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANALOK
• Version Model Number: 213025
• Catalog Number: 213025
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705002580 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[10886705002580]

Moist Heat or Steam Sterilization

[10886705002580]

Moist Heat or Steam Sterilization

[10886705002580]

Moist Heat or Steam Sterilization

[10886705002580]

Moist Heat or Steam Sterilization

[10886705002580]

Moist Heat or Steam Sterilization

[10886705002580]

Moist Heat or Steam Sterilization

[10886705002580]

Moist Heat or Steam Sterilization

[10886705002580]

Moist Heat or Steam Sterilization

[10886705002580]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-09-20
• Device Publish Date: 2015-09-01

On-Brand Devices [PANALOK]

• 10886705000982: PANALOK Absorbable Anchor 3.5mm Size 1 (4 metric) PDS II (polydioxanone) suture, 36 Inches (91cm
• 10886705002597: PANALOK Slotted Drill Guide Sawtooth
• 10886705002580: PANALOK Slotted Drill Guide Fishmouth
• 10886705001439: ARTHROSCOPIC PANALOK RC DRILL BIT 3.2mm x 25mm
• 10886705001422: PANALOK RC Drill Bit 3.2mm x 25mm
• 10886705001415: PANALOK Drill Bit-Spade Tip 3.5mm x 18mm
• 10886705001408: PANALOK Drill Bit 3.5mm