FDA.reportPublic FDA data

EDG® Ortho 65mm

Primary DI
00865707000414
Brand
EDG® Ortho 65mm
Company
EDGE SURGICAL, INC.
Model
21342-65-01
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.
Published
2018-02-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOLElectronic Depth Gauge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOLElectronic Depth GaugeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091992000EIDOSMED, MODEL EDG4.0Eidosmed, LLC2009-12-09OOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10865707000411PackageGS110In Commercial Distribution
00865707000414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086570700041110865707000411
00865707000414008657070004148657070004140865707000414

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, single-useA sterile surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 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. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room temp in a cool dry place

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
855-765-3249info@edgesurgical.com

Regulatory Flags#

DUNS number
080787313
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865707000438EDG® Ortho 65mm21342-65-01-10-LN2025-05-07
00865707000445EDG® Ortho 65mm21342-65-01-40-LN2025-05-07
10865707000435EDG® Ortho 65mm21342-65-01-10-LN2025-05-07
10865707000442EDG® Ortho 65mm21342-65-01-40-LN2025-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00865707000438EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2025-05-07
00865707000445EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2025-05-07
10865707000435EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2025-05-07
10865707000442EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2025-05-07