MOUNTAINEER 188363200

GUDID 10705034159027

MOUNTAINEER OCT SPINAL SYSTEM PRE-BENT SPINAL ROD 3.5 x 120mm - 85mm

Medos International Sàrl

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034159027
• NIH Device Record Key: 161e25f8-9bf3-4d67-b06d-ff7f3c593e7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOUNTAINEER
• Version Model Number: 188363200
• Catalog Number: 188363200
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034159027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042508

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

[10705034159027]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-04
• Device Publish Date: 2015-09-24

On-Brand Devices [MOUNTAINEER]

• 10705034466392: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5 5.5mm x 900mm
• 10705034466385: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5 5.5mm x 900mm
• 10705034290713: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.0 x 24mm
• 10705034290706: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.0 x 22mm
• 10705034290690: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.0 x 20mm
• 10705034290683: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 3.5 x 24mm
• 10705034290676: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 3.5 x 22mm
• 10705034290638: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 50mm
• 10705034290621: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 45mm
• 10705034290614: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 40mm
• 10705034290607: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 35mm
• 10705034290591: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 30mm
• 10705034290584: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 25mm
• 10705034290577: MOUNTAINEER OCT SPINAL SYSTEM MINI POLYAXIAL BONE SCREW 3.5 x 4.35 x 20mm
• 10705034290560: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 400mm
• 10705034290553: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 340mm
• 10705034290546: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 300mm
• 10705034290539: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 200mm
• 10705034290522: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 120mm
• 10705034290515: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 100mm
• 10705034290508: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 95mm
• 10705034290492: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 90mm
• 10705034290485: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 85mm
• 10705034290478: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 80mm
• 10705034290461: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 75mm
• 10705034290454: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 70mm
• 10705034290447: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 65mm
• 10705034290430: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 60mm
• 10705034290423: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 55mm
• 10705034290416: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 50mm
• 10705034290409: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 45mm
• 10705034290393: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 40mm
• 10705034290386: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 35mm
• 10705034290379: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 30mm
• 10705034290362: MOUNTAINEER OCT SPINAL SYSTEM STRAIGHT ROD 3.5mm x 25mm
• 10705034290355: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 4.5mm x 600mm
• 10705034290348: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 6.35mm x 600mm
• 10705034290331: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 5.5mm x 600mm
• 10705034290324: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 4.75mm x 600mm
• 10705034290317: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 4.5mm x 420mm
• 10705034290300: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 6.35mm x 420mm
• 10705034290294: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 5.5mm x 420mm
• 10705034290287: MOUNTAINEER OCT SPINAL SYSTEM DUAL DIAMETER ROD 3.5mm - 4.75mm x 420mm
• 10705034159089: MOUNTAINEER OCT SPINAL SYSTEM LATERAL WASHER 2mm
• 10705034159072: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL ADJUSTABLE ROD 3.5 x 120mm - 72mm
• 10705034159058: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL ADJUSTABLE ROD 3.5 x 220mm - 72mm
• 10705034159034: MOUNTAINEER OCT SPINAL SYSTEM OC ROD CAP SCREW 3.5
• 10705034159027: MOUNTAINEER OCT SPINAL SYSTEM PRE-BENT SPINAL ROD 3.5 x 120mm - 85mm
• 10705034159010: MOUNTAINEER OCT SPINAL SYSTEM PRE-BENT SPINAL ROD 3.5 x 200mm - 85mm
• 10705034159003: MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL BONE SCREW 5.25 x 16mm