AccessGUDID - DEVICE: Chest Depth Caliper (00855170007232)

GUDID

Device Identifier (DI) Information

Brand Name: Chest Depth Caliper
Version or Model: 01140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01140
Company Name: LAFAYETTE INSTRUMENT COMPANY, INC.

Primary DI Number: 00855170007232
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005080650 *Terms of Use

Device Description: The Chest Depth Caliper accurately measures chest depth in inches or centimeters. Popular uses include measuring maximum chest expansion from resting to full inspiration. Range is from 0 to 24 inches in 0.50 inch graduations (0 to 60 cm with 2.0 cm graduations).

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:	No
Prescription Use (Rx):	No
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?
48167	General-purpose calliper, plastic	A non-sterile, manually-operated, lubricant free, plastic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of reinforced plastic that cannot be steam sterilized. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTZ	Caliper

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 40 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a2fc722b-1844-426c-b226-fd26a15d3402
Public Version Date: June 14, 2023
Public Version Number: 2
DI Record Publish Date: August 31, 2021