AccessGUDID - DEVICE: EDG® Ortho 65mm (00865707000445)

GUDID

Device Identifier (DI) Information

Brand Name: EDG® Ortho 65mm
Version or Model: 21342-65-01-40-LN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EDGE SURGICAL, INC.

Primary DI Number: 00865707000445
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080787313 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOL	Electronic Depth Gauge

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091992	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -24 and 60 Degrees Celsius
Storage Environment Temperature: between -24 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 65 Millimeter
Device Size Text, specify: 4mm offset

Device Record Status

Public Device Record Key: 85421e6d-89eb-4695-9860-a734cb05ae70
Public Version Date: May 15, 2025
Public Version Number: 1
DI Record Publish Date: May 07, 2025