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 Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use 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