AccessGUDID - DEVICE: Proscope™ (00634782014728)

GUDID

Device Identifier (DI) Information

Brand Name: Proscope™
Version or Model: 670NYZ
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 670NYZ
Company Name: AMERICAN DIAGNOSTIC CORP

Primary DI Number: 00634782014728
Issuing Agency: GS1
Commercial Distribution End Date: April 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 108999095 *Terms of Use

Device Description: Dualhead Scope,22", Neon Yellow, Gen

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):	Yes
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?
13755	Mechanical external stethoscope	A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the user’s ears. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDE	Stethoscope, Manual

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: 8cb30164-e5c8-4d9b-82ff-c57583c3ba14
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: October 14, 2016