Surgical depth gauge, single-use

FDA UDI

Class I (US FDA UDI)

by Fci S A S Fci 20 22

Identity

Trade Name: Surgical depth gauge, single-use FDA UDI
Generic Name: Surgical depth gauge, single-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: SIZER FOR SELF-RETAINING BICANALICULUS INTUBATION FDA UDI
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. FDA UDI

Identifiers

Catalog Number: S1.1289U FDA UDI
Primary DI / UDI-DI: 03760087120257 FDA UDI
FDA Product Code: HNL FDA UDI
GMDN Term: Surgical depth gauge, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Length — 80 Millimeter FDA UDI

Category: Surgical depth gauge, single-use

Surgical depth gauge, single-use by Fci S A S Fci 20 22 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Surgical Direct — SURGICAL DIRECT, INC. · Class I
DVR® CROSSLOCK EPAK™DEPTH GAUGE — Biomet Orthopedics, Inc. · Class I
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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Fci S A S Fci 20 22

Sources (1)

FDA UDI 3b676a1a-e26e-4597-a6f6-dcf069a011e2 36 fields · synced May 30, 2026