SURGICAL INSTRUMENT MI 3415

GUDID 07899995210746

IMPLANT FIXER MICRO MINI LONG

Sin Sistema de Implante Nacional S/A

Dental implant holding endpiece

• Primary Device ID: 07899995210746
• NIH Device Record Key: 5de8887f-25ad-4d16-b6d0-c19cfb7a50de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGICAL INSTRUMENT
• Version Model Number: MI 3415
• Catalog Number: MI 3415
• Company DUNS: 904569092
• Company Name: Sin Sistema de Implante Nacional S/A
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	07899995210746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201688

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-07
• Device Publish Date: 2021-03-30

On-Brand Devices [SURGICAL INSTRUMENT]

• 07899995296320: SURGICAL HAMMER
• 07899995270122: MALE DRILL Ø4,0MM
• 07899995270115: MALE DRILL Ø6,0MM
• 07899995270108: MALE DRILL Ø5,0MM
• 07899995209856: MALE THREAD IMP 3.25
• 07899995206411: DRIVER HANDPIECE UNITITE COMPACT LONG
• 07899995206404: DRIVER HANDPIECE UNITITE COMPACT SHORT
• 07899995205445: MALE DRILL Ø 5,0MM
• 07899995205438: MALE DRILL Ø 4,3MM
• 07899995205421: MALE DRILL Ø 3,5MM
• 07899995205407: MALE DRILL Ø 2,9MM
• 07899995205094: DRIVER HAND HEX 1.2X24
• 07899995215109: PROSTHETIC TORQUE FIXER
• 07899995213631: OSTEOTOME SUMMER W/ STOP N 4
• 07899995213624: OSTEOTOME SUMMER W/ STOP N 3
• 07899995213617: OSTEOTOME SUMMER W/ STOP N 2
• 07899995213600: OSTEOTOME SUMMER W/ STOP N 1
• 07899995213594: DEPTH ROUNDER STRAIGHT
• 07899995213587: DEPTH ROUNDER ANGULATED
• 07899995211538: LONG LIP PROTECTOR
• 07899995211521: SHORT LIP PROTECTOR
• 07899995208651: DRILL SPHERICAL Ø3.0
• 07899995208514: DRILL PILOT ZYGOMATIC
• 07899995208408: DRILL HELICAL ZYGOMATIC Ø3.55
• 07899995208392: DRILL HELICAL ZYGOMATIC Ø2.95
• 07899995207364: DRIVER HANDPIECE C. MORSE LONG
• 07899995207340: DRIVER HANDPIECE C. MORSE
• 07899995207319: ROTARY EXPANDER N 04
• 07899995207302: ROTARY EXPANDER N 03
• 07899995207296: ROTARY EXPANDER N 02
• 07899995207289: ROTARY EXPANDER N 01
• 07899995206800: DRIVER HANDPIECE UNITIE SLIM LONG
• 07899995206749: DRIVER HANDPIECE UNITITE SLIM SHORT
• 07899995206435: DRIVER HANDPIECE UNITITE MORSE LONG
• 07899995206428: DRIVER HANDPIECE UNITITE MORSE SHORT
• 07899995206374: MALE DRILL IMP Ø5,0MM
• 07899995206367: MALE DRILL IMP Ø4,5MM
• 07899995206350: MALE DRILL IMP Ø3,8MM
• 07899995206343: MALE DRILL IMP Ø3,75MM
• 07899995206336: MALE DRILL IMP Ø3,5MM
• 07899995205506: DRIVER SQUARE TORQUE 24
• 07899995205490: DRIVE SQUARE TORQUE 20
• 07899995205483: DRIVE HANDPIECE
• 07899995205476: PROSTHETIC DRUM
• 07899995205452: DRIVER HANDS IMPLANT ZYGOMATIC
• 07899995205377: DRIVER HANDPIECE LONG HEX. INTER
• 07899995205360: DRIVER HANDPIECE SHORTY HEX. INTER
• 07899995205292: DRIVER SQUARE TORQUE 24
• 07899995205155: DRIVER TORQUE HEX. 1.2X24
• 07899995205148: DRIVER TORQUE HEX. 1.2X20