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 ID00865707000414
NIH Device Record Keyb3e89c9b-ca81-4dfb-bdc8-b626afee8df3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDG® Ortho 65mm
Version Model Number21342-65-01
Company DUNS080787313
Company NameEDGE SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com
Phone855-765-3249
Emailinfo@edgesurgical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Room temp in a cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100865707000414 [Primary]
GS110865707000411 [Package]
Package: corrugated box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOLElectronic Depth Gauge

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[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

[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

[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

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

[00865707000414]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-12-07
Device Publish Date2018-02-28
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.