AccessGUDID - DEVICE: PremierPro (00818566011732)

GUDID

Device Identifier (DI) Information

Brand Name: PremierPro
Version or Model: 2536
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2536
Company Name: SVS LLC

Primary DI Number: 00818566011732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831375089 *Terms of Use

Device Description: PremierPro Disposable Coveralls PP White Elastic Cuffs and Open Ankles XX-Large 5/bg

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):	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
LYU	Accessory, Surgical Apparel
OEA	Non-Surgical Isolation Gown

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: 410200b4-70c5-4ecf-bb6d-4cedb46ce902
Public Version Date: August 05, 2020
Public Version Number: 1
DI Record Publish Date: July 28, 2020