AccessGUDID - DEVICE: Surgical depth gauge, single-use (03760087120257)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical depth gauge, single-use
Version or Model: SIZER FOR SELF-RETAINING BICANALICULUS INTUBATION
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S1.1289U
Company Name: FCI S A S FCI 20 22

Primary DI Number: 03760087120257
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 763408366 *Terms of Use

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

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
HNL	Probe, Lachrymal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 80 Millimeter

Device Record Status

Public Device Record Key: 3b676a1a-e26e-4597-a6f6-dcf069a011e2
Public Version Date: November 23, 2021
Public Version Number: 2
DI Record Publish Date: March 06, 2020