HYGITECH HY-110042
GUDID 03615140001533
HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. To avoid thermal damage to the bone, the surgical drill must be properly cooled with the proper flow of coolant; this flow rate can be set directly on the motor. It will be imperative to use a suitable and compatible irrigation set for an implantology motor in particular. Each HYGITECH irrigation set is equipped with: A perforator, for the sterile solution bag, and an ON / OFF air filter to increase the flow of the saline solution. A flow control wheel to control or cut the flow of the solution. A silicone peristaltic pump tube adapted to the dimensions of each physio dispenser. A stopcock that is present on some references to regulate the different flow Accessories in reference functions: S-shaped fasteners: attaches the irrigation tube to the micro motor cord. Hooks: When the diameter of the implantology cord is large, use these hooks to attach it to the irrigation set. Y connector: to choose between one or two channels. The dentist can use a single lane for internal or external irrigation or both lanes to irrigate simultaneously internally and externally. Conditioning Each irrigation set is packaged in a sterile blister pack. There are two traceability labels on each blister: these labels include the batch number, reference, and expiration date of the product to facilitate the transfer of information to the patient record. Box of 10 sets. All brand names are registred trademarks and property of the manufacturer
HYGITECH
Oral lavage system| Primary Device ID | 03615140001533 |
| NIH Device Record Key | b7b65039-f558-4a45-9799-f995d179b9a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYGITECH |
| Version Model Number | HY-110042 |
| Catalog Number | HY-110042 |
| Company DUNS | 279456896 |
| Company Name | HYGITECH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03615140001526 [Primary] |
| GS1 | 03615140001533 [Package] Contains: 03615140001526 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 03615140001540 [Package] Package: Carton [10 Units] In Commercial Distribution |
FDA Product Code
| EFS | Unit, Oral Irrigation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-23 |
| Device Publish Date | 2020-12-15 |
On-Brand Devices [HYGITECH]
| 03615140003735 | The Surgical drapes consists in a protective barrier offering a resistance to bacteria penetra |
| 03615140002790 | The sterile sleeve provides excellent protection for tubing while guaranteeing the best sanitary |
| 03615140002769 | Single use sterile mirror, 21mm diameter with anti-fog treatment. Handle length: 14 cm. Advantag |
| 03615140002578 | Ideal for short procedures or simple patient visits. Packed in a transparent plastic peel pack t |
| 03615140002479 | The IMPLANFIELD kit is designed for protecting the operating theatre. It is recommended for surg |
| 03615140002448 | The sterile sleeve provides excellent protection for tubing while guaranteeing the best sanitary |
| 03615140002189 | Standard isolation gown with cotton cuffs, sterile with polypropylene layer 30g/m². Available i |
| 03615140002158 | Standard isolation gown with cotton cuffs, sterile with polypropylene layer 30g/m². Available i |
| 03615140002035 | Precise and effective suction cannula, which reaches the narrowest areas. Each box contains 2 au |
| 03615140001977 | Specially for implantologists, it can be fixed to any standard PVC tube or to any surgical sucti |
| 03615140001946 | Precise and effective suction cannula, which reaches the narrowest areas. Each box contains 2 au |
| 03615140001915 | Sterile transparent PVC suction tube with 2 connectors at the extremities. Length: 2.70m |
| 03615140001885 | Suction device composed of a surgical cannula pre-installed at the end of the PVC aspirator tube |
| 03615140001748 | HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on |
| 03615140001687 | HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on |
| 03615140001625 | HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on |
| 03615140001595 | HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on |
| 03615140001564 | HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on |
| 03615140000468 | A single squeeze activation makes this cold therapy pack immediately reach a safe, therapeutic t |
| 03615140003827 | These drapes are composed of 2 layers: 1 absorbent spunlace layer (24g/m²) 1 waterproof PP laye |
| 03615140003766 | Sterile dual layered surgical drape, absorbent and impermeable, ensures the best protection! Cov |
| 03615140003704 | Standard waterproof absorbent surgical drape. Sterile dual layered surgical drape, absorbent and |
| 03615140003674 | Dental chair covers provide an effective barrier against bacteria, protecting the patient from c |
| 03615140003643 | Dental chair covers provide an effective barrier against bacteria, protecting the patient from c |
| 03615140003599 | Standard waterproof absorbent surgical drape. Sterile dual layered surgical drape, absorbent and |
| 03615140003544 | Standard waterproof absorbent surgical drape. Sterile dual layered surgical drape, absorbent and |
| 03615140003513 | Cover the patient and keep his eyes uncovered. U-shaped cutout on the shorter side with adhesive |
| 03615140003483 | Standard quality : White, soft, high quality wadding paper towel |
| 03615140003452 | Standard quality : White, soft, high quality wadding paper towel |
| 03615140003421 | This polyethylene x-ray bouffant cover will offer maximum protection against cross-contamination |
| 03615140003391 | Sterile dual layered surgical drape, absorbent and impermeable, ensures the best protection! Cov |
| 03615140003360 | Sterile dual layered surgical drape, absorbent and impermeable, ensures the best protection! Cov |
| 03615140003339 | Cover the patient and keep his eyes uncovered. U-shaped cutout on the shorter side with adhesive |
| 03615140003223 | - Cost effective: These covers reduce the need to use disinfectants and protect the dental chair |
| 03615140003193 | - Cost effective: These covers reduce the need to use disinfectants and protect the dental chair |
| 03615140003162 | Standard waterproof absorbent surgical drape. Sterile dual layered surgical drape, absorbent and |
| 03615140003131 | Standard waterproof absorbent surgical drape. Sterile dual layered surgical drape, absorbent and |
| 03615140003100 | Standard waterproof absorbent surgical drape. Sterile dual layered surgical drape, absorbent and |
| 03615140003070 | The HYGITECH transparent bag with sliding bootlace allows to protect the control unit without c |
| 03615140005265 | The PROTECT kit is HYGITECH’s best selling kit, designed to meet all needs for any type of imp |
| 03615140003858 | Effective and comfortable waterproof protection for the patient White cover with elastic lining, |
| 03615140000208 | The HYGITECH loupe is an optical instrument developed to facilitate visualisation of specific ob |
| 03615140000185 | The HYGITECH loupe is an optical instrument developed to facilitate visualisation of specific ob |
| 03615140003957 | Complete article: Autoclavable frame, single use shields Anti-fog treatment Vertical inclination |
| 03615140003940 | Complete article: Autoclavable frame, single use shields Anti-fog treatment Vertical inclination |
| 03615140003933 | Complete article: Autoclavable frame, single use shields Anti-fog treatment Vertical inclination |
| 03615140000130 | Complete article: Autoclavable frame, single use shields Anti-fog treatment Vertical inclination |
| 03615140000116 | The support for suction pockets is an accessory which can be attached to the shaft of the HYGITE |
| 03615140000109 | HYGITECH waste bucket is made of stainless steel 18/10 AISI 304. Great mobility: 4 wheels of 50m |
| 03615140000093 | Ideal support for an implantology motor during implant surgery. Dimensions: 31.5 x 27.5 cm Maxim |
Trademark Results [HYGITECH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYGITECH 74533068 1938025 Dead/Cancelled |
Hygitech, Inc. 1994-06-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.