AccessGUDID - DEVICE: HYGITECH (03615140005296)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-09011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-09011
Company Name: HYGITECH

Primary DI Number: 03615140005296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: Duo kit HYGITECH Reference: HY-09011 The DUO kit is the kit needed for dressing both the surgeon and his assistant. some environment protection is also included, which makes this kit perfect for all kinds of procedures. The kit is composed of 32 items. 4 Polyethylene gloves 1 surgical drape (29.5"x 29.5"/ 75x75cm) 2 Elastic cap handle covers 2 Protective sleeves for tubing (3.5"x 47"/ 8x120cm) 3 non-latex elastic bands 1 Adhesive protective cover for control panel (6.3"x 8.9"/ 16x22cm) 1 surgical cap 2 Bouffant caps 2 tie-on masks 2 Pairs of overshoes 1 surgical brush with nail cleaner 4 Paper hand-towels 1 assistant gown with cotton cuffs 1 surgical gown with cotton cuffs 1 U-shaped surgical drape with adhesive (31.5"x 39"/ 80x100cm) 1 Wrapping paper

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?
11171	Denture repair kit, professional	A collection of devices used in dentistry by a dentist or dental laboratory technician to repair cracks or breaks in a denture. It will contain the necessary materials and components, e.g., resins, adhesives/glues, mixing utensils, and an applicator. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDD	Kit, Surgical Instrument, Disposable

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: d2b0ad4d-5c72-4372-9471-4a21a2123a34
Public Version Date: December 24, 2020
Public Version Number: 1
DI Record Publish Date: December 16, 2020