EDG® Ortho 65mm

GUDID 00865707000414

The EDG® Ortho 65mm is a singe-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriately length of screw in orthopedic procedures. This device comes sterile and ready to use once removed from its packaging.

EDGE SURGICAL, INC.

Surgical depth gauge, single-use

• Primary Device ID: 00865707000414
• NIH Device Record Key: b3e89c9b-ca81-4dfb-bdc8-b626afee8df3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDG® Ortho 65mm
• Version Model Number: 21342-65-01
• Company DUNS: 080787313
• Company Name: EDGE SURGICAL, 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: true
• 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: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com
• Phone: 855-765-3249
• Email: info@edgesurgical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Room temp in a cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865707000414 [Primary]
GS1	10865707000411 [Package]; Package: corrugated box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091992

FDA Product Code

• OOL: Electronic Depth Gauge

Sterilization

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

[00865707000414]

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[00865707000414]

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[00865707000414]

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[00865707000414]

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[00865707000414]

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[00865707000414]

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[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

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Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-02-28

On-Brand Devices [EDG® Ortho 65mm]

• 00865707000414: The EDG® Ortho 65mm is a singe-use electronic depth gauge used to measure the depth of a cavity
• 10865707000442: EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i
• 10865707000435: EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i