Implant Kit

GUDID 08056646500840

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.

OMNIA SRL

General/plastic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 08056646500840
• NIH Device Record Key: 64993a50-faf7-43fc-aaeb-0a72291b34cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant Kit
• Version Model Number: 12.XYYYY.00
• Company DUNS: 447696675
• Company Name: OMNIA SRL
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056646500840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110724

FDA Product Code

• LRO: General Surgery Tray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-12
• Device Publish Date: 2020-02-04

Devices Manufactured by OMNIA SRL

• 08052141311400 - Irrigation line, Kavo: 2023-08-16 Sterilizable Hose Set S600
• 08052141311424 - Irrigation line, Kavo: 2023-08-16 Hose set for Kavo INTRASurg (10/pkg)
• 08052141310014 - Transparent bag 67x75 cm with sliding ties for physiodispensers or for control u: 2023-07-06 Transparent bag 67x75 cm with sliding ties for physiodispensers or for control units
• 08056646505739 - Omnicover: 2023-07-06 Round waterproof headrest cover Ø 22 cm with elastic Shell Cover
• 08056646505890 - Universal seat cover and backrest cover Shell Cover: 2023-07-06 Universal seat cover and backrest cover Shell Cover
• 08056646508563 - Transparent drape 40x50 cm with adhesive tape for physiodispensers or for contro: 2023-07-06 Transparent drape 40x50 cm with adhesive tape for physiodispensers or for control units
• 08056646508587 - Sheaths 120x7 cm with fixing elastics: 2023-07-06 Sheaths 120x7 cm with fixing elastics
• 08056646508600 - Sheaths 240x7 cm cm with fixing elastics: 2023-07-06 Sheaths 240x7 cm cm with fixing elastics