EDG® Ortho 65mm

Basic Information

• Brand Name: EDG® Ortho 65mm
• Primary DI: 00865707000414
• Version / Model: 21342-65-01
• Company Name: EDGE SURGICAL, INC.
• Labeler DUNS: 080787313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-28
• Public Version: 6
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: b3e89c9b-ca81-4dfb-bdc8-b626afee8df3

Device Description

The 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 appropriately length of screw in orthopedic procedures. This device comes sterile and ready to use once removed from its packaging.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OOL	Electronic Depth Gauge	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58796	Surgical depth gauge, single-use	A surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone to determine the length of the bone screw to be used. It may take the form of: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced; or 3) a cylindrical rod with markings. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00865707000414	GS1
Package	10865707000411	GS1	corrugated box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K091992	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room temp in a cool dry place