FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140005210
·
Model: HY-08511
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140005210
- Version / Model
- HY-08511
- Catalog Number
- HY-08511
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-16
- Public Version
- 1
- Public Version Date
- 2020-12-24
- Public Version Status
- New
- Public Device Record Key
- 78ee11df-0060-4556-8ace-f73737665405
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
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03615140005227 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 03615140005210 | GS1 |