AccessGUDID - DEVICE: 30cm Short Arm Anthropometer (00855170007393)

GUDID

Device Identifier (DI) Information

Brand Name: 30cm Short Arm Anthropometer
Version or Model: 01291A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01291A
Company Name: LAFAYETTE INSTRUMENT COMPANY, INC.

Primary DI Number: 00855170007393
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005080650 *Terms of Use

Device Description: The 30cm Short Arm Anthropometer accurately measures distance in cm. It features a fixed arm and a measurement arm that slides along a scale. The scale indicates the distance between the two arms. Calipers are used to measure body characteristics such as abdominal diameter, wrist, elbow and knee widths, muscle mass, shoulder and chest width, etc. The measurements are accurate to 1mm.

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?
32262	General-purpose calliper, metallic	A manually-operated metallic 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 stainless steel or chrome-plated steel and can be sterilized in a steam sterilizer (an autoclave). 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: 41ddd31b-4fb3-4d30-ab9f-47d40fa8bdd5
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023