HYGITECH HY-07001
GUDID 03615140003933
Complete article: Autoclavable frame, single use shields Anti-fog treatment Vertical inclination Frame available in 3 colours: white, blue, pink Light: 22 grams Comfortable frame, it adapts to all face types Handy: Shields easy to fit Perfect protection: 30cm shield protects the whole face The shield assures clear vision, Abrasion and scratch-resistant
HYGITECH
Face splash shield, single-use| Primary Device ID | 03615140003933 |
| NIH Device Record Key | 89484272-9bf0-4294-b91e-15ca45fd1354 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYGITECH |
| Version Model Number | HY-07001 |
| Catalog Number | HY-07001 |
| Company DUNS | 279456896 |
| Company Name | HYGITECH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | 03615140000147 [Primary] |
| GS1 | 03615140003933 [Package] Contains: 03615140000147 Package: Box [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173062
FDA Product Code
| FXX | Mask, Surgical |
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 | 2020-12-22 |
| Device Publish Date | 2020-12-14 |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.