Contours VPS Volar Plating System DH0434CE

GUDID 18054242516200

DRILL BIT, 1.6 MM, QUICK CONNECT

ORTHOFIX SRL

Fluted surgical drill bit, reusable

• Primary Device ID: 18054242516200
• NIH Device Record Key: a6da2c08-b31d-4f68-a838-6379d33164cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contours VPS Volar Plating System
• Version Model Number: 1
• Catalog Number: DH0434CE
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: true
• 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: 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

Customer Support Contacts

• Phone: +390456719000
• Email: info@orthofix.it
• Phone: +390456719000
• Email: info@orthofix.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242516200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042766

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[18054242516200]

Moist Heat or Steam Sterilization

[18054242516200]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-12-01

On-Brand Devices [Contours VPS Volar Plating System]

• 18054242517078: PLATE, DISTAL RADIUS VOLAR, RIGHT, WIDE, LONG
• 18054242517061: PLATE, DISTAL RADIUS VOLAR, RIGHT, WIDE, SHORT
• 18054242517054: PLATE, DISTAL RADIUS VOLAR, RIGHT, STANDARD, XLONG
• 18054242517047: PLATE, DISTAL RADIUS VOLAR, RIGHT, STANDARD, LONG
• 18054242517030: PLATE, DISTAL RADIUS VOLAR, RIGHT, STANDARD, SHORT
• 18054242517023: PLATE, DISTAL RADIUS VOLAR, RIGHT, NARROW, LONG
• 18054242517016: PLATE, DISTAL RADIUS VOLAR, RIGHT, NARROW, SHORT
• 18054242517009: PLATE, DISTAL RADIUS VOLAR, MOD SCREW ANGLES, RIGHT, C1, LONG LENGTH, TITANIUM
• 18054242516996: PLATE, DISTAL RADIUS VOLAR, MOD SCREW ANGLES, RIGHT, C1, STD LENGTH, TITANIUM
• 18054242516989: PLATE, VOLAR DISTAL RADIUS, RIGHT, C2, LONG LENGTH, TITANIUM
• 18054242516972: PLATE, VOLAR DISTAL RADIUS, RIGHT, C1, LONG LENGTH, TITANIUM
• 18054242516965: PLATE, VOLAR DISTAL RADIUS, RIGHT, C2, STD LENGTH, TITANIUM
• 18054242516958: PLATE, VOLAR DISTAL RADIUS, RIGHT, C1, STD LENGTH, TITANIUM
• 18054242516941: PLATE, DISTAL RADIUS VOLAR, LEFT, WIDE, LONG
• 18054242516934: PLATE, DISTAL RADIUS VOLAR, LEFT, WIDE, SHORT
• 18054242516927: PLATE, DISTAL RADIUS VOLAR, LEFT, STANDARD, XLONG
• 18054242516910: PLATE, DISTAL RADIUS VOLAR, LEFT, STANDARD, LONG
• 18054242516903: PLATE, DISTAL RADIUS VOLAR, LEFT, NARROW, LONG
• 18054242516897: PLATE, DISTAL RADIUS VOLAR, LEFT, NARROW, LONG
• 18054242516880: TEMPLATE FOR VPS3 PLATE
• 18054242516873: PLATE, DISTAL VOLAR RADIUS, MOD. SCREW ANGLES, LEFT, C1, LONG LENGTH, TITANIUM
• 18054242516866: PLATE, DISTAL VOLAR RADIUS, MOD. SCREW ANGLES, LEFT, C1, STD LENGTH, TITANIUM
• 18054242516859: PLATE, VOLAR DISTAL RADIUS, LEFT, C2, LONG LENGTH, TITANIUM
• 18054242516842: PLATE, VOLAR DISTAL RADIUS, LEFT, C1, LONG LENGTH, TITANIUM
• 18054242516835: PLATE, VOLAR DISTAL RADIUS, LEFT, C2, STD LENGTH, TITANIUM
• 18054242516828: PLATE, VOLAR DISTAL RADIUS, LEFT, C1, STD LENGTH, TITANIUM
• 18054242516811: SCREW, 3.5 MM X 1.25 X 18 MM W/2.5 MM HEX, BONE
• 18054242516804: SCREW, 3.5 MM X 1.25 X 16 MM W/2.5 MM HEX, BONE
• 18054242516798: SCREW, 3.5 MM X 1.25 X 14 MM W/2.5 MM HEX, BONE
• 18054242516781: SCREW, 3.5 MM X 1.25 X 12 MM W/2.5 MM HEX, BONE
• 18054242516774: SCREW, 3.5 MM X 1.25 X 10 MM W/2.5 MM HEX, BONE
• 18054242516767: SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 20 MM ASTM TYPE HA, TITANIUM
• 18054242516750: SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 18 MM ASTM TYPE HA, TITANIUM
• 18054242516743: SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 16 MM ASTM TYPE HA, TITANIUM
• 18054242516736: SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 14 MM ASTM TYPE HA, TITANIUM
• 18054242516729: SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 12 MM ASTM TYPE HA, TITANIUM
• 18054242516712: SCREW, DISTAL RADIUS VOLAR, 3.5 MM X 10 MM ASTM TYPE HA, TITANIUM
• 18054242516705: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 28X21, TITANIUM
• 18054242516699: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 26X19.5, TITANIUM
• 18054242516682: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 24X18, TITANIUM
• 18054242516675: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 22X16.5, TITANIUM
• 18054242516668: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 20X15, TITANIUM
• 18054242516651: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 18X13.5, TITANIUM
• 18054242516644: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 16X12, TITANIUM
• 18054242516637: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 14X10.5, TITANIUM
• 18054242516620: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.7 MM TYPE HA, 12X8.5, TITANIUM
• 18054242516613: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.4 MM TYPE HA, 24X18, TITANIUM
• 18054242516606: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.4 MM TYPE HA, 22X16.5, TITANIUM
• 18054242516590: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.4 MM TYPE HA, 20X15, TITANIUM
• 18054242516583: SCREW, DISTAL RADIUS VOLAR, M3.5X0.6 W/2.4 MM TYPE HA, 18X13.5, TITANIUM