AccessGUDID - DEVICE: American Eagle Instruments (00841013115967)

GUDID

Device Identifier (DI) Information

Brand Name: American Eagle Instruments
Version or Model: MH6-7X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERICAN EAGLE INSTRUMENTS, INC.

Primary DI Number: 00841013115967
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790776850 *Terms of Use

Device Description: No description.

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):	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?
35321	Bed scale	A transportable electronic device designed to measure and display the body weight of a patient occupying a bed and who is unable to vacate the bed. It is available in a variety of designs such as a slab-like padded board suspended by metal brackets from a trolley (cart) that contains a weighing mechanism onto which the patient is moved (rolled from the bed onto the slab), or more commonly a system whereby the entire bed (with patient) is weighed and the known weight of the bed and the bedding is subtracted to provide the patient's weight (e.g., pads containing transducers are placed under each wheel or leg of the bed and connected to the electronic weighing unit).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMN	SCALER, PERIODONTIC

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a58c8fda-c6db-4d31-b666-2f235355908a
Public Version Date: October 05, 2022
Public Version Number: 3
DI Record Publish Date: May 23, 2022