Surgical depth gauge, single-use

Basic Information

• Brand Name: Surgical depth gauge, single-use
• Primary DI: 03760087120257
• Version / Model: SIZER FOR SELF-RETAINING BICANALICULUS INTUBATION
• Catalog Number: S1.1289U
• Company Name: FCI S A S FCI 20 22
• Labeler DUNS: 763408366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-03-06
• Public Version: 2
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: 3b676a1a-e26e-4597-a6f6-dcf069a011e2

Device Description

A sterile surgical instrument designed to accurately determine the depth of a recess (usually a drilled hole). It typically consists of a moveable (sliding) centerpiece (a prong), the tip of which is inserted into the recess; when the tip makes contact with the bottom a reading is visually taken from a scale marked on the side of the device. It is often used 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 is made of corrosive resistant materials [e.g., stainless steel, titanium (Ti), plastics]. This is a single-use device.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNL	Probe, Lachrymal	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	53760087120252	GS1
Primary	03760087120257	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	80	Millimeter