AccessGUDID - DEVICE: HYGITECH (03615140005159)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-0981
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-0981
Company Name: HYGITECH

Primary DI Number: 03615140005159
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: Protect Plus kit HYGITECH Reference: HY-0981 The PROTECT PLUS kit is HYGITECH's most comprehensive kit, offering a variety of products to ensure the full protection of the surgery, including drapes and clothing for the surgeon, assistant and patient. Each kit contains 58 items. 4 Polyethylene gloves 2 Tie-on masks 2 Surgical hats 3 Bouffant caps 1 Patient gown with cotton cuffs 2 Surgical gowns with cotton cuffs 1 Pair of overshoes for patient 2 Pairs of non-slip overshoes 2 Sterile brushes with nail cleaner 4 Paper hand-towels 2 Saliva ejectors 3 Adhesive protective covers for control panel 1 Protective PVC X-ray cover 2 Adhesive films (2" x 31.5" / 5x80cm) 1 Chair cover with 6 ties 4 Protective sleeves for tubing (3.5" x 47" / 8 x 120cm) 3 Non-latex elastic bands 2 Elastic cap handle covers 1 Tube support with adhesive 1 Surgical drape (59" x 59" / 150x150cm) with adhesive 1 Absorbent drape (59" x 59" / 150x150cm) with adhesive 2 Surgical drapes (39" x 39" / 100x100 cm) with adhesive 1 Surgical drape with aperture and adhesive (27.5" x 31.5" / 70x80cm) 1 Surgical drape with aperture (27.5" x 31.5" / 70x80cm) 2 Ice bags 1 Plastic bag (20" x 31.5" / 50x80cm) 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: dea799ad-1d6b-4c71-8608-d861060c7650
Public Version Date: December 24, 2020
Public Version Number: 1
DI Record Publish Date: December 16, 2020