AccessGUDID - DEVICE: HYGITECH (03615140003810)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-634
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-634
Company Name: HYGITECH

Primary DI Number: 03615140003810
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: These drapes are composed of 2 layers: 1 absorbent spunlace layer (24g/m²) 1 waterproof PP layer (30g/m²) More info They can cover the equipment, Mayo tables, bridge tables and the patient Sticking on the shorter side For the whole range SURFACES PROTECTION For the product Effective barrier to fight against cross contaminations in non autoclavable elements, like dental chairs Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer 3 sizes, for all purposes Really strong and tear-resistant Compliant with the 13795-3 European norm

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?
33520	Surgical drape adhesive	A spray, typically aerosol, intended to be applied to the skin to cause a surgical drape to adhere to the body. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KKX	Drape, 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: 6a5e8e91-4cdb-4970-a8a9-797be2da2e3c
Public Version Date: December 15, 2020
Public Version Number: 2
DI Record Publish Date: November 25, 2020