FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140003728
·
Model: HY1-630
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140003728
- Version / Model
- HY1-630
- Catalog Number
- HY1-630
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-13
- Public Version
- 1
- Public Version Date
- 2020-10-21
- Public Version Status
- New
- Public Device Record Key
- f8f15fff-c98c-4bfb-a19e-07b8858d0d25
Device Description
The Surgical drapes consists in a protective barrier offering a resistance to bacteria penetration during dental acts and an effective fluid control system in order to reduce the risk of surgical site infection. Sterile surgical Drapes are available in order to contribute and improve the preparation of the surgical room by preventing cross-contamination. It could be placed: On the patient: to cover the patient, the operated area during the surgical operation. It could also absorb exudate during the operation. On the operating room furniture which will be used as a support for any surgical instrumentation. The device is useful to protect the patient and environment’s surgeon.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03615140003735 | GS1 | Box | 30 | In Commercial Distribution | |
| Primary | 03615140003728 | GS1 | ||||
| Package | 03615140003742 | GS1 | Carton | 4 | In Commercial Distribution |