AccessGUDID - DEVICE: Strong Manufacturers (00850040791174)

GUDID

Device Identifier (DI) Information

Brand Name: Strong Manufacturers
Version or Model: 7101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7101
Company Name: Strong Medical Partners LLC

Primary DI Number: 00850040791174
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062388929 *Terms of Use

Device Description: Manual stethoscope used to project the sounds associated with the heart, arteries, veins and other internal organs. Single head, yellow, not made with natural rubber latex. Case of 25 each.

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":	Yes
For Single-Use:	Yes
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
Special Storage Condition, Specify: Store in packaging; clean instrument with soft, damp lint-free fabric. Disinfect with alcohol.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2dd5f1d5-3b9f-42df-9a40-0e6e985ac30a
Public Version Date: November 25, 2024
Public Version Number: 2
DI Record Publish Date: August 19, 2022