HYGITECH
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140000178
- Version / Model
- HY-07104
- Catalog Number
- HY-07104
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-14
- Public Version
- 1
- Public Version Date
- 2020-12-22
- Public Version Status
- New
- Public Device Record Key
- 834cd99a-3ebc-42b0-b96a-3a0f0d69b1d0
Device Description
The HYGITECH loupe is an optical instrument developed to facilitate visualisation of specific objects or areas. It was conceived for all precise work as well as helping improve performance of dental surgeons during technical procedures. Characteristics : • A Velcro strap allows comfortable adjustment of the loupe around the head • The loupe can be moved up and down to better align the eyes with the magnified area • The unbreakable lenses protect the eyes, help your eyes adjust quickly and comfortably and give the exact hue of the magnified object • Available in two magnifications, x2.5 or x3.5 Ergonomic - Perfectly adjustable around the head, the loupe’s ergonomics offer true comfort and incomparable ease of use. Light - Weighing only 70g, the HYGITECH loupe is remarkably light. Practical - Allowing assistance during technical procedures, the loupe helps give the dental surgeon a better approach to the surgical field
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FXX | Mask, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12319 | Lens loop, reusable | A hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03615140000185 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 03615140000178 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173062 | 000 |