FDA.reportPublic FDA data

EDG® Ortho 65mm

Primary DI
10865707000442
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
OTC
false
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
00865707000445EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2025-05-07
10865707000435EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2025-05-07
00865707000414EDG® Ortho 65mmEDGE SURGICAL, INC.OOL2018-02-28