EDG® Ortho 65mm

GUDID 10865707000435

EDG® Ortho 65mm is a single-use electronic depth gauge used to measure the depth of a cavity (i.e. bone screw hole) to enable surgeons to select the appropriate length of screw in orthopedic procedures. This device some sterile and ready-to-use once removed from its packaging. This DI is appropriate for plating systems that require a 1mm offset depth gauge.

EDGE SURGICAL, INC.

Surgical depth gauge, single-use

• Primary Device ID: 10865707000435
• NIH Device Record Key: 202d1f60-fd3c-439e-aa4b-bd97bb090ef2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDG® Ortho 65mm
• Version Model Number: 21342-65-01-10-LN
• 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: true
• 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

Device Dimensions

• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -24 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865707000438 [Primary]
GS1	10865707000435 [Package]; Contains: 00865707000438; 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

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

[10865707000435]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-15
• Device Publish Date: 2025-05-07

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