AccessGUDID - DEVICE: Hilo (00860008076595)

GUDID

Device Identifier (DI) Information

Brand Name: Hilo
Version or Model: S4005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Hilo Enterprises LLC

Primary DI Number: 00860008076595
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 117057129 *Terms of Use

Device Description: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size XX-LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407. Color: Blue

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?
35091	Surgical gown, single-use	A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYA	Gown, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: b9c38ac4-fae9-4bc2-a94a-d6552aaa009f
Public Version Date: August 02, 2023
Public Version Number: 2
DI Record Publish Date: January 04, 2022