5MS

GUDID 00817906028195

COMPRESSION DRILL GUIDE, Ø1.6 & Ø1.9, ASSY

IN2BONES USA, LLC

Orthopaedic fixation implant alignment tool

• Primary Device ID: 00817906028195
• NIH Device Record Key: 7138ed05-bd1d-4f84-a6dd-1430d45620e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5MS
• Version Model Number: P06 N0581
• Company DUNS: 079700711
• Company Name: IN2BONES USA, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817906028195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170518

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

[00817906028195]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-10-22

On-Brand Devices [5MS]

• 00817906028317: 5MS, PLANTAR PLATE, LARGE, TRIAL, 4H
• 00817906028300: 5MS, PLANTAR PLATE, LARGE, TRIAL, 5H
• 00817906028294: 5MS, PSEUDO JONES PLATE TRIAL
• 00817906028287: 5MS, BUNIONETTE PLATE, L, TRIAL
• 00817906028270: 5MS, BUNIONETTE PLATE, R, TRIAL
• 00817906028263: 5MS, LATERAL NECK PLATE, 6H, L, TRIAL
• 00817906028256: 5MS, LATERAL NECK PLATE, 8H, L, TRIAL
• 00817906028249: 5MS, LATERAL NECK PLATE, 6H, R, TRIAL
• 00817906028232: 5MS, LATERAL NECK PLATE, 8H, R, TRIAL
• 00817906028225: 5MS, PLANTAR PLATE, TRIAL, 4H
• 00817906028218: 5MS, PLANTAR PLATE, TRIAL, 5H
• 00817906028201: COMPRESSION DRILL GUIDE, Ø2.0 & Ø2.5, ASSY
• 00817906028195: COMPRESSION DRILL GUIDE, Ø1.6 & Ø1.9, ASSY
• 00817906028188: 5MS, PSEUDO JONES PLATE TAMP
• 00817906028171: 5MS, LOCKING DRILL GUIDE, Ø1.9
• 00817906028164: 5MS, LOCKING DRILL GUIDE, Ø1.6
• 00817906028157: 5MS, JONES SCREW SIZER
• 00810021869421: 5MS, REDUCTION FORCEPS, NON-STERILE
• 00810021866123: 5MS, PLATE BENDING IRON, NON-STERILE
• 00810021864365: 5MS, PSEUDO JONES PLATE, LONG TRIAL, NON-STERILE
• 00810021864037: 5MS, PSEUDO JONES PLATE, Long