AccessGUDID - DEVICE: HYGITECH (03615140000345)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-058
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-058
Company Name: HYGITECH

Primary DI Number: 03615140000345
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: The surgeon, the assistant and the patient all have the potential to bring dust and bacteria into the operating room. The mat contains 30 disposable sheets. Simply peel off and dispose of each sheet when soiled. To prevent the spreading of bacterial contamination from room to room, HYGITECH has created a mat with an acrylic sticky surface treated with a substance which attacks and neutralises the bacterial content present in the residues retained by the mat. Advantages: - Non-slip PVC base - Numbered layers for checking the remaining capacity - Dimensions : 60x120cm

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?
35582	Decontamination floor mat, reusable	A pad made of coarse, durable material that is designed to be placed on the floor to wipe the soles of the footwear of persons walking on its surface. The product is intended to reduce the distribution of dirt/contaminated materials on the floor. This product can be reused after appropriate cleaning procedures.	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: 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: 17220d0f-25f0-42b6-a708-8beb85ada57a
Public Version Date: December 23, 2020
Public Version Number: 1
DI Record Publish Date: December 15, 2020