HYGITECH
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140002899
- Version / Model
- HY-066
- Catalog Number
- HY-066
- 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
- 1
- Public Version Date
- 2020-12-23
- Public Version Status
- New
- Public Device Record Key
- a758dc19-bfa9-4327-9b2b-5f61048356d3
Device Description
The 90cm Hygitech protective sleeve efficiently protects all tubing while guaranteeing the sterility of the operating room. These PVC single-use sleeves were specifically created with dental surgeons in mind. Characterisitics/Properties : - The sleeve’s dimensions allow the protection of tubing 90cm in length and 8,5cm in width - The sleeves contain an adhesive which giving good grip on the tubing - The box contains 250 sleeves Inpermeable surface protection - Effective barrier for non-autoclavable equiptment in order to combat cross-contamination - Protection against bacteria and viruses which limits the use of disinfectants and prolongs the lifespan of equiptment Strength - Rip Resistant Easy to use - Thanks to the adhesive at the end of the sleeves
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | 878.4040 | 1 |
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 | 03615140002905 | GS1 | Carton | 6 | In Commercial Distribution | |
| Primary | 03615140002899 | GS1 |