AccessGUDID - DEVICE: HYGITECH (03615140003414)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-63115
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-63115
Company Name: HYGITECH

Primary DI Number: 03615140003414
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: This polyethylene x-ray bouffant cover will offer maximum protection against cross-contamination when covering your x-ray material, microscopes or dental lights. Internal diameter: 20cm. External diameter: 50cm.

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?
62934	Surgical dressing/drape kit, single-use	A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXP	Cover, Shoe, Operating-Room

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: 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: f2dd1ce9-8f02-40e0-b24b-28405ed37947
Public Version Date: June 22, 2021
Public Version Number: 4
DI Record Publish Date: November 25, 2020