Polyaxial Drill Guide Sleeve MDS110803

GUDID 10812269020425

Polyaxial Drill Guide Sleeve for K-Wire Ø1.6mm

MIAMI DEVICE SOLUTIONS LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 10812269020425
• NIH Device Record Key: d5d5514b-a7f1-482e-8035-340e9ca175a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polyaxial Drill Guide Sleeve
• Version Model Number: MDS110803
• Catalog Number: MDS110803
• Company DUNS: 078703080
• Company Name: MIAMI DEVICE SOLUTIONS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: (786) 422-1400
• Email: customerservice@miamidevicesolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812269020425 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[10812269020425]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2017-01-25

On-Brand Devices [Polyaxial Drill Guide Sleeve]

• 10812269021989: Polyaxial Drill Guide Sleeve for K-Wire Ø1.1mm
• 10812269020425: Polyaxial Drill Guide Sleeve for K-Wire Ø1.6mm