VIPER 186788300

GUDID 10705034132259

VIPER 2 SYSTEM ROD, PRE-LORDOSED 300mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034132259
• NIH Device Record Key: 007b0990-1d48-4bf5-b99a-75956a025ebf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIPER
• Version Model Number: 186788300
• Catalog Number: 186788300
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034132259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071860

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

[10705034132259]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-05-03
• Device Publish Date: 2015-09-24

On-Brand Devices [VIPER]

• 10705034303499: VIPER 2 SYSTEM REDUCTION DRIVER SHAFT 5.5 x25
• 10705034214757: VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5
• 10705034214689: VIPER 2 SYSTEM THREADED REDUCTION CAP 5.5
• 10705034214665: VIPER 2 SYSTEM REDUCTION THREADED POST 5.5
• 10705034214580: VIPER 2 SYSTEM SET SCREW INSERTER, SELF-RETAINING
• 10705034214573: VIPER 2 SYSTEM APPROXIMATING SET SCREW INSERTER, SELF-RETAINING
• 10705034214481: VIPER SYSTEM SET SCREW INSERTER X25
• 10705034214382: VIPER 2 SYSTEM MULTI-PIECE SCREW EXTENSION CASTLE NUT REMOVER
• 10705034214542: VIPER 2 SYSTEM ROD HOLDER, ADVANCED
• 10705034214528: VIPER 2 SYSTEM ROD HOLDER, BOLT
• 10705034214504: VIPER 2 SYSTEM ROD HOLDER, ANGLED
• 10705034214467: VIPER SYSTEM ROD HOLDER, ANGLED
• 10705034214450: VIPER SYSTEM ROD PUSHER GUIDE
• 10705034214436: VIPER SYSTEM ROD HOLDER BOLT
• 10705034213460: VIPER SYSTEM ALIGNMENT GUIDE
• 10705034303420: VIPER 2 SYSTEM LARGE DIAMETER POLY CADDY
• 10705034303413: VIPER 2 SYSTEM SCREW CADDY 4.35
• 10705034303406: VIPER 2 SYSTEM SCREW HALF TRAY 4.35
• 10705034303390: VIPER 2 SYSTEM LARGE DIAMETER HALF TRAY
• 10705034303383: VIPER 2 SYSTEM REDUCTION TRAY
• 10705034303376: VIPER 2 SYSTEM ROD ROTATION TRAY
• 10705034303369: VIPER 2 SYSTEM PEDICLE CANNULATION TRAY
• 10705034303352: VIPER 2 SYSTEM DEROTATION TRAY
• 10705034303345: VIPER 2 SYSTEM COMPRESSION/DISTRACTION TRAY
• 10705034215020: VIPER 2 SYSTEM GENERIC MIS 3 LEVEL CASE
• 10705034214993: VIPER 2 SYSTEM EXT. TAB INSTRUMENT TRAY
• 10705034214986: VIPER 2 SYSTEM EXT. TAB IMPLANT TRAY
• 10705034213767: VIPER 2 SYSTEM LONG SCREW CADDY
• 10705034213750: VIPER 2 SYSTEM MONOAXIAL CADDY
• 10705034213743: VIPER 2 SYSTEM UNIPLANAR CADDY
• 10705034213736: VIPER 2 SYSTEM SCREW CADDY 6mm
• 10705034213729: VIPER 2 SYSTEM SCREW CADDY 5/7mm
• 10705034213705: VIPER 2 SYSTEM ROD CADDY
• 10705034213637: VIPER 2 SYSTEM VIPER 3D CASE AND TRAY
• 10705034213620: VIPER 2 SYSTEM TRAY LID
• 10705034213613: VIPER 2 SYSTEM IMPLANT TRAY
• 10705034213606: VIPER 2 SYSTEM CASE 3 TRAY 2
• 10705034213590: VIPER 2 SYSTEM CASE 3 TRAY 1
• 10705034213583: VIPER 2 SYSTEM CASE 2 TRAY 2
• 10705034213576: VIPER SYSTEM HALF TRAY LID
• 10705034213569: VIPER 2 SYSTEM LID
• 10705034213552: VIPER 2 SYSTEM CASE 2 TRAY 1
• 10705034213545: VIPER 2 SYSTEM CASE 1 TRAY 2
• 10705034213538: VIPER 2 SYSTEM CASE 1 TRAY 1
• 10705034213521: VIPER 2 SYSTEM LONG SCREW HALF TRAY
• 10705034213514: VIPER 2 SYSTEM CASE
• 10705034213507: VIPER SYSTEM CANNULATED SCREW CADDY 5.5 x 7.5mm
• 10705034213491: VIPER SYSTEM CANNULATED SCREW CADDY 7.0mm
• 10705034213484: VIPER SYSTEM CANNULATED SCREW CADDY 6.0mm
• 10705034213477: VIPER SYSTEM CANNULATED SCREW CADDY 5.5 x 5mm