AccessGUDID - DEVICE: HCS (00849027001382)

GUDID

Device Identifier (DI) Information

Brand Name: HCS
Version or Model: HCS3001XL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DYAD MEDICAL SOURCING, LLC

Primary DI Number: 00849027001382
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 078572603 *Terms of Use

Device Description: Gown Cover, SMS AAMI Level 2, Blue, X-Large, Elastic Cuff Tie Waist, Neck Tab Closure, Latex Free

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?
32170	Professional examination gown, single-use	A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FME	Gown, Examination

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: 827ee365-430f-44af-a17b-a03cb3e0b8bd
Public Version Date: April 03, 2023
Public Version Number: 2
DI Record Publish Date: December 31, 2019