HYGITECH HY-07106

GUDID 03615140000208

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

HYGITECH

Lens loop, reusable

• Primary Device ID: 03615140000208
• NIH Device Record Key: db9b831a-ee8d-477a-8f34-345c703c9556
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYGITECH
• Version Model Number: HY-07106
• Catalog Number: HY-07106
• 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	03615140000192 [Primary]
GS1	03615140000208 [Package]; Contains: 03615140000192; 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