OMNIA SRL

Address:VIA F.DELNEVO 190,FIDENZA Parma,IT

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Device Description : PTFE Suture 45 cm - 7/0 - Extra Cutting tip - 10 mm Needle 3/8 - Reverse Cutting

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 12

Device Description : Indication For Use: Surgical Procedure Packs is a kit for oral implantology, use Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries.Surgical Procedure Packs may be packages as a combination of any of the following components: - Surgical gowns (various models) with or without hand towels- Surgical Drapes:- Mayo drape- Absorbent/liquid proof drapes (with or without adhesive)- Adhesive side drape- Liquid repellent drape with or without adhesive- Face mask- Protective caps- Sheath/tubing sleeve- Surgical aspirator with adaptor- Surgical gauze- Disinfection sponge and/or basin- Adhesive films- Syringe- Needles- Single-use scalpel- Small dental mirror/dental explorer/tweezer- Irrigation/infusion line- Stopcock and ramp for infusion- Waste bag for contaminated material- Bone collector- Saliva ejector- Basin- Medical paperPossible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI"Model Number:X = alphabetic characterYYYY= n° of 4 number character

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : LRO, KKX, FYA, FXX

Prescription Use : Yes

Device Count : 1

Device Description : The sterile "Procedural Packages for Diagnosis and Surgery" are intended for use The sterile "Procedural Packages for Diagnosis and Surgery" are intended for use by specialized personnel and are composed of consumables and devices intended for the preparation of the operating field, maintenance of cleanliness (ensuring the hygiene of the field and limiting the risk of contamination) and the performance of various types of surgery.The devices provided can be:- non-invasive devices, for the preparation of the operating field - for example: drapes, gowns, masks and accessories (bandages, sheaths, tool pockets, bags for collecting liquids, fixed pliers for drapes, etc.)- invasive surgical devices for temporary use not in contact with the central circulatory system and with the nervous system - for example: needles and syringes with needle, disposable scalpels and gauze.- devices for channeling liquids intended for irrigation.Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI" Model number : X = alphabetic character YYYY=n° of 4 number character.

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : LRO, KKX, FYA, FXX

Prescription Use : Yes

Device Count : 1

Device Description : 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 3/0 CUTTING 19MM 3/8 CIRCLE R 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 3/0 CUTTING 19MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 3

Device Description : 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 3/0 CUTTING 16MM 3/8 CIRCLE R 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 3/0 CUTTING 16MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 3

Device Description : 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 CUTTING 19MM 3/8 CIRCLE R 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 CUTTING 19MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 3

Device Description : 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 EXTRA CUTTING 12MM 3/8 CI 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 EXTRA CUTTING 12MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 3

Device Description : 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 CUTTING 12MM 3/8 CIRCLE R 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 CUTTING 12MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 3

Device Description : 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 CUTTING 16MM 3/8 CIRCLE R 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 CUTTING 16MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 3

Device Description : 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 5/0 EXTRA CUTTING 10MM 3/8 CI 3-PC Sample for PTFE SUTURE - HU-FRIEDY - 45 CM - 5/0 EXTRA CUTTING 10MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 3