FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140002721
·
Model: HY-05702
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140002721
- Version / Model
- HY-05702
- Catalog Number
- HY-05702
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-15
- Public Version
- 2
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- d77e31c5-4b29-472c-97f4-ad7fe61526a3
Device Description
In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered. The protection film helps fight cross-contamination by becoming a valid protection barrier for all the surfaces. Convenient: Easy to tear off and apply. Its delicate adhesive layer makes the protecttion film easily removable without damaging your equipment or walls. Supplied as a box of 50 adhesive sheets of 16 x 22.50 cm.
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 |
|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03615140002738 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 03615140002721 | GS1 | ||||
| Package | 03615140002745 | GS1 | Carton | 4 | In Commercial Distribution |