TMJ SYSTEM SP-2328

GUDID 00841036134204

BIOMET MICROFIXATION, INC

Fluted surgical drill bit, reusable

• Primary Device ID: 00841036134204
• NIH Device Record Key: f81c5d9b-950c-42ba-9337-b14f020b85cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMJ SYSTEM
• Version Model Number: SP-2328
• Catalog Number: SP-2328
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• 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: 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(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036134204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062842

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

[00841036134204]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2015-10-11

On-Brand Devices [TMJ SYSTEM]

• 00841036036379: 2.0MM/ 2.7MM TMJ DOUBLE ENDED DRILL GUIDE
• 00841036198121: SP-1874-INT
• 00841036155100: SP-2896
• 00841036151348: SP-1873-INT
• 00841036147549: 2.3X11MM FOSSA CROSS-DRIVE SCREW
• 00841036140144: 2.3X5MM FOSSA CROSS-DRIVE SCREW
• 00841036138776: 2.0X13MM FOSSA CROSS-DRIVE SCREW
• 00841036134204: SP-2328
• 00841036134198: SP-2327
• 00841036129309: INSTRUMENT TRAY
• 00841036128692: 2.0X5MM FOSSA CROSS-DRIVE SCREW
• 00841036124991: SCREW / TRIAL TRAY
• 00841036081898: 50 MM LEFT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT
• 00841036081881: 50 MM RIGHT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT
• 00841036081874: 45 MM LEFT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT
• 00841036081867: 45 MM RIGHT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT
• 00841036081805: 50 MM LEFT NARROW TITANIUM MANDIBULAR COMPONENT
• 00841036081799: 50 MM RIGHT NARROW TITANIUM MANDIBULAR COMPONENT
• 00841036081782: 45 MM LEFT NARROW TITANIUM MANDIBULAR COMPONENT
• 00841036081744: 55 MM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT
• 00841036081737: 50 MM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT
• 00841036081720: 50 MM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT
• 00841036081713: 45 MM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT
• 00841036081560: 45 MM LEFT STANDARD OFFSET MANDIBULAR COMPONENT
• 00841036081553: 45 MM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT
• 00841036081386: 45 MM RIGHT NARROW TITANIUM MANDIBULAR COMPONENT
• 00841036081348: 55 MM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT
• 00841036075118: 45 MM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT
• 00841036064884: 50 MM LEFT STANDARD OFFSET MANDIBULAR COMPONENT
• 00841036063580: 50 MM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT
• 00841036060534: TWIST DRILL WITH J-NOTCH 2.2X70,12STP
• 00841036060428: 50MM RIGHT STANDARD MANDIBULAR COMPONENT
• 00841036060398: 55 MM RIGHT STANDARD MANDIBULAR COMPONENT
• 00841036060343: 50 MM RIGHT STANDARD MANDIBULAR COMPONENT
• 00841036060329: 50 MM LEFT STANDARD MANDIBULAR COMPONENT
• 00841036057480: 2.3X9MM FOSSA CROSS-DRIVE SCREW
• 00841036057473: 2.3X7MM FOSSA CROSS-DRIVE SCREW
• 00841036057466: 2.0X11MM FOSSA CROSS-DRIVE SCREW
• 00841036057459: 2.0X9MM FOSSA CROSS-DRIVE SCREW
• 00841036057442: 2.0X7MM FOSSA CROSS-DRIVE SCREW
• 00841036039271: DINGMAN BONE HOLDING FORCEPS HEAVY PATTERN
• 00841036039264: DINGMAN BONE HOLDING FORCEPS LIGHT PATTERN
• 00841036036683: TWIST DRILL WITH J-NOTCH 2.2X115,12STP
• 00841036036676: TWIST DRILL WITH J-NOTCH 2.0X115,12STP
• 00841036036669: TWIST DRILL WITH J-NOTCH 2.0X70,12STP
• 00841036036652: TWIST DRILL WITH J-NOTCH 1.5X105,11 STP
• 00841036036645: TWIST DRILL WITH J-NOTCH 1.5X50,11 STP
• 00841036036638: LEFT FOSSA COMPONENT TRIAL LARGE
• 00841036036621: LEFT FOSSA COMPONENT, LARGE
• 00841036036614: RIGHT FOSSA COMPONENT TRIAL LARGE