AccessGUDID - DEVICE: HYGITECH (03615140005210)

GUDID

Device Identifier (DI) Information

Brand Name: HYGITECH
Version or Model: HY-08511
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HY-08511
Company Name: HYGITECH

Primary DI Number: 03615140005210
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 279456896 *Terms of Use

Device Description: Implanwear kit HYGITECH Reference: HY-08511 The IMPLANWEAR kit is intended for heavy implant surgeries involving a surgeon, an assistant and the patient. It contains all clothing items needed to protect 3 people. The kit is composed of 28 items. 2 Surgical hats 3 Bouffant caps 1 Pair of patient overshoes 2 Pairs of non-slip overshoes 3 Tie-on masks 2 Surgical brushes with nail cleaner 6 Paper hand-towels 1 Assistant gown with cotton cuffs 1 Patient gown with cotton cuffs 1 Surgical gown with cotton cuffs 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: 78ee11df-0060-4556-8ace-f73737665405
Public Version Date: December 24, 2020
Public Version Number: 1
DI Record Publish Date: December 16, 2020