E³ MIS Pedicle Screw System 06-03N

GUDID 00842048121138

Rod Inserter, Offset

DEGEN MEDICAL, INC.

Instrument tray

• Primary Device ID: 00842048121138
• NIH Device Record Key: 7dcba46d-fc47-4138-9a4e-7cf9a437d7e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E³ MIS Pedicle Screw System
• Version Model Number: 06-03N
• Catalog Number: 06-03N
• Company DUNS: 078812602
• Company Name: DEGEN MEDICAL, 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: false
• 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(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842048121138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173814

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

[00842048121138]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-04-16

On-Brand Devices [E³ MIS Pedicle Screw System]

• 00842048121435: Mini Tower
• 00842048121145: Rod Inserter, Straight
• 00842048121138: Rod Inserter, Offset
• 00842048121121: Mini Tower Reduction
• 00842048121114: Screw, CC, Solid, 10.0 X 130mm
• 00842048121107: Screw, CC, Solid, 10.0 X 125mm
• 00842048121091: Screw, CC, Solid, 10.0 X 120mm
• 00842048121084: Screw, CC, Solid, 10.0 X 115mm
• 00842048121077: Screw, CC, Solid, 10.0 X 110mm
• 00842048121060: Screw, CC, Solid, 10.0 X 105mm
• 00842048121053: Screw, CC, Solid, 10.0 X 100mm
• 00842048121046: Screw, CC, Solid, 10.0 X 95mm
• 00842048121039: Screw, CC, Solid, 10.0 X 90mm
• 00842048121022: Screw, CC, Solid, 10.0 X 85mm
• 00842048121015: Screw, CC, Solid, 10.0 X 80mm
• 00842048121008: Screw, CC, Solid, 10.0 X 75mm
• 00842048120995: Screw, CC, Solid, 10.0 X 70mm
• 00842048120988: Screw, CC, Solid, 10.0 X 65mm
• 00842048120971: Screw, CC, Solid, 10.0 X 60mm
• 00842048120964: Screw, CC, Solid, 10.0 X 55mm
• 00842048120957: Screw, CC, Solid, 10.0 X 50mm
• 00842048120940: Screw, CC, Solid, 10.0 X 45mm
• 00842048120933: Screw, CC, Solid, 10.0 X 40mm
• 00842048120926: Screw, CC, Solid, 10.0 X 35mm
• 00842048120919: Screw, CC, Solid, 10.0 X 30mm
• 00842048120902: Screw, CC, Solid, 9.5 X 130mm
• 00842048120896: Screw, CC, Solid, 9.5 X 125mm
• 00842048120889: Screw, CC, Solid, 9.5 X 120mm
• 00842048120872: Screw, CC, Solid, 9.5 X 115mm
• 00842048120865: Screw, CC, Solid, 9.5 X 110mm
• 00842048120858: Screw, CC, Solid, 9.5 X 105mm
• 00842048120841: Screw, CC, Solid, 9.5 X 100mm
• 00842048120834: Screw, CC, Solid, 9.5 X 95mm
• 00842048120827: Screw, CC, Solid, 9.5 X 90mm
• 00842048120810: Screw, CC, Solid, 9.5 X 85mm
• 00842048120803: Screw, CC, Solid, 9.5 X 80mm
• 00842048120797: Screw, CC, Solid, 9.5 X 75mm
• 00842048120780: Screw, CC, Solid, 9.5 X 70mm
• 00842048120773: Screw, CC, Solid, 9.5 X 65mm
• 00842048120766: Screw, CC, Solid, 9.5 X 60mm
• 00842048120759: Screw, CC, Solid, 9.5 X 55mm
• 00842048120742: Screw, CC, Solid, 9.5 X 50mm
• 00842048120735: Screw, CC, Solid, 9.5 X 45mm
• 00842048120728: Screw, CC, Solid, 9.5 X 40mm
• 00842048120711: Screw, CC, Solid, 9.5 X 35mm
• 00842048120704: Screw, CC, Solid, 9.5 X 30mm
• 00842048120698: Screw, CC, Solid, 9.0 X 130mm
• 00842048120681: Screw, CC, Solid, 9.0 X 125mm
• 00842048120674: Screw, CC, Solid, 9.0 X 120mm
• 00842048120667: Screw, CC, Solid, 9.0 X 115mm