AccessGUDID - DEVICE: HYGITECH (03615140000307)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-057
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-057
Company Name: HYGITECH

Primary DI Number: 03615140000307
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: Convenient - Easy to tear off and apply Its delicate adhesive layer makes Hygifilm easily removable without damaging your equipment or walls. - Supplied as a roll of 10cm x 14,5xm pre-perforated adhesive sheets, presented in a dispenser box. In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered. Hygifilm helps fight cross-contamination by isolating all surfaces that are impossible or difficult to autoclave: dental light handles, computer mice, computer control panel, keyboards and telephones.

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?
10035	Skin surface device adhesive	A substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTY	Tape, Measuring, Rulers And Calipers

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: c232c4df-19cf-40bc-bc5a-ecbea7cd3b64
Public Version Date: November 09, 2022
Public Version Number: 2
DI Record Publish Date: December 15, 2020