AccessGUDID - DEVICE: HYGITECH (03615140002837)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-060
Company Name: HYGITECH

Primary DI Number: 03615140002837
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: HYGITECH polyethylene protection sleeves enable you to cover hand pieces, cables, turbines and contra-angles. Effective barrier to fight against cross contamination. Practical: Sleeves are easily separated one from another via the dispenser box. Resistant and easy to use. Sleeves must to be changed after every patient Dimensions: 4.5 or 5,5cm x45 cm long, Ø2.8 cm, conical end Ø1.5cm

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: 7bbb6879-ac9f-4bbd-b26e-29fcedbb2f27
Public Version Date: November 09, 2022
Public Version Number: 2
DI Record Publish Date: December 15, 2020