FDA.reportPublic FDA data

EDG® Ortho 65mm

Primary DI
00865707000445
Brand
EDG® Ortho 65mm
Company
EDGE SURGICAL, INC.
Model
21342-65-01-40-LN
Device description
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 4mm offset depth gauge
Published
2025-05-07
Public version status
New
Distribution status
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
10865707000442PackageGS110In Commercial Distribution
00865707000445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086570700044210865707000442
00865707000445008657070004458657070004450865707000445

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length65Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-24 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-24 Degrees Celsius60 Degrees Celsius

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
Manufacturing date on label
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
10865707000435EDG® Ortho 65mm21342-65-01-10-LN2025-05-07
10865707000442EDG® Ortho 65mm21342-65-01-40-LN2025-05-07
00865707000414EDG® Ortho 65mm21342-65-012018-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00865707000438EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2025-05-07
10865707000435EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2025-05-07
10865707000442EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2025-05-07
00865707000414EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2018-02-28