SURGICAL PROCEDURE PACK

GUDID 8056646500239

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 paper 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 ID8056646500239
NIH Device Record Key183a0d1f-653a-41dc-ae2f-58e5d39bea87
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGICAL PROCEDURE PACK
Version Model Number12.XYYYY.00
Company DUNS447696675
Company NameOMNIA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu
Phone+390524527453
Emailinfo@omniaspa.eu

Device Identifiers

Device Issuing AgencyDevice ID
GS108056646500222 [Primary]
GS108056646500529 [Package]
Contains: 08056646500222
Package: 12.S9835.00 [30 Units]
In Commercial Distribution
GS108056646500536 [Package]
Contains: 08056646500222
Package: 12.E0777.00 [15 Units]
In Commercial Distribution
GS108056646500543 [Package]
Contains: 08056646500222
Package: 12.E0815.00 [10 Units]
In Commercial Distribution
GS108056646500550 [Package]
Contains: 08056646500222
Package: 12.S8317.00 [10 Units]
In Commercial Distribution
GS108056646500567 [Package]
Contains: 08056646500222
Package: 12.E0276.00 [10 Units]
In Commercial Distribution
GS108056646500574 [Package]
Contains: 08056646500222
Package: 12.E0960.00 [6 Units]
In Commercial Distribution
GS108056646500581 [Package]
Contains: 08056646500222
Package: 12.E0960.00 [6 Units]
Discontinued: 2017-11-07
Not in Commercial Distribution
GS108056646500598 [Package]
Contains: 08056646500222
Package: 12.E1186.00 [8 Units]
In Commercial Distribution
GS108056646500604 [Package]
Contains: 08056646500222
Package: 12.E1276.00 [20 Units]
In Commercial Distribution
GS108056646500611 [Package]
Contains: 08056646500222
Package: 12.E1202.00 [10 Units]
In Commercial Distribution
GS108056646500628 [Package]
Contains: 08056646500222
Package: 12.E1248.00 [10 Units]
In Commercial Distribution
GS108056646500635 [Package]
Contains: 08056646500222
Package: 12.E1318.00 [15 Units]
In Commercial Distribution
GS108056646500642 [Package]
Contains: 08056646500222
Package: 12.E1338.00 [6 Units]
In Commercial Distribution
GS108056646500659 [Package]
Contains: 08056646500222
Package: 12.E0646.00 [20 Units]
In Commercial Distribution
GS108056646500666 [Package]
Contains: 08056646500222
Package: 12.E1407.00 [5 Units]
In Commercial Distribution
GS108056646500673 [Package]
Contains: 08056646500222
Package: 12.S9671.00 [6 Units]
In Commercial Distribution
GS108056646500680 [Package]
Contains: 08056646500222
Package: 12.E1591.00 [25 Units]
In Commercial Distribution
GS108056646500697 [Package]
Contains: 08056646500222
Package: 12.E1561.00 [12 Units]
In Commercial Distribution
GS108056646500703 [Package]
Contains: 08056646500222
Package: 12.E1805.00 [6 Units]
In Commercial Distribution
GS108056646500710 [Package]
Contains: 08056646500222
Package: 12.E1910.00 [8 Units]
In Commercial Distribution
GS108056646500727 [Package]
Contains: 08056646500222
Package: 12.E2068.00 [20 Units]
In Commercial Distribution
GS108056646500734 [Package]
Contains: 08056646500222
Package: 12.E1857.00 [6 Units]
In Commercial Distribution
GS108056646500758 [Package]
Contains: 08056646500222
Package: 12.E2354.00 [8 Units]
In Commercial Distribution
GS108056646500765 [Package]
Contains: 08056646500222
Package: 12.E2458.00 [10 Units]
In Commercial Distribution
GS108056646500772 [Package]
Contains: 08056646500222
Package: 12.E2468.00 [40 Units]
In Commercial Distribution
GS108056646500789 [Package]
Contains: 08056646500222
Package: 12.E2619.00 [8 Units]
In Commercial Distribution
GS108056646500796 [Package]
Contains: 08056646500222
Package: 12.S8382.00 [5 Units]
In Commercial Distribution
GS108056646500802 [Package]
Contains: 08056646500222
Package: 12.S4913.00 [8 Units]
In Commercial Distribution
GS108056646500819 [Package]
Contains: 08056646500222
Package: 12.S6003.00 [15 Units]
In Commercial Distribution
GS108056646500826 [Package]
Contains: 08056646500222
Package: 12.E1619.00 [2 Units]
In Commercial Distribution
GS180566465000505 [Package]
Contains: 08056646500222
Package: 12.E0054.00 [5 Units]
Discontinued: 2016-12-12
Not in Commercial Distribution
GS18056646500239 [Package]
Contains: 08056646500222
Package: 12.T0010.00 [6 Units]
In Commercial Distribution
GS18056646500246 [Package]
Contains: 08056646500222
Package: 12.T0001.00 [6 Units]
In Commercial Distribution
GS18056646500253 [Package]
Contains: 08056646500222
Package: 12.T0002.00 [6 Units]
In Commercial Distribution
GS18056646500260 [Package]
Contains: 08056646500222
Package: 12.T0107.00 [6 Units]
In Commercial Distribution
GS18056646500277 [Package]
Contains: 08056646500222
Package: 12.T0108.00 [6 Units]
In Commercial Distribution
GS18056646500284 [Package]
Contains: 08056646500222
Package: 12.T0105.00 [10 Units]
In Commercial Distribution
GS18056646500291 [Package]
Contains: 08056646500222
Package: 12.S5621.00 [10 Units]
In Commercial Distribution
GS18056646500307 [Package]
Contains: 08056646500222
Package: 12.S4671.00 [6 Units]
In Commercial Distribution
GS18056646500314 [Package]
Contains: 08056646500222
Package: 12.S4041.00 [6 Units]
In Commercial Distribution
GS18056646500321 [Package]
Contains: 08056646500222
Package: 12.S4096.00 [1 Units]
In Commercial Distribution
GS18056646500338 [Package]
Contains: 08056646500222
Package: 12.S4061.00 [1 Units]
In Commercial Distribution
GS18056646500345 [Package]
Contains: 08056646500222
Package: 12.T0003.00 [6 Units]
In Commercial Distribution
GS18056646500352 [Package]
Contains: 08056646500222
Package: 12.T0013.00 [6 Units]
In Commercial Distribution
GS18056646500369 [Package]
Contains: 08056646500222
Package: 12.S5557.00 [5 Units]
In Commercial Distribution
GS18056646500376 [Package]
Contains: 08056646500222
Package: 12.S6007.00 [8 Units]
In Commercial Distribution
GS18056646500383 [Package]
Contains: 08056646500222
Package: 12.E0052.00 [2 Units]
In Commercial Distribution
GS18056646500390 [Package]
Contains: 08056646500222
Package: 12.S9306.00 [50 Units]
In Commercial Distribution
GS18056646500406 [Package]
Contains: 08056646500222
Package: 12.S9307.00 [20 Units]
In Commercial Distribution
GS18056646500413 [Package]
Contains: 08056646500222
Package: 12.S9308.00 [100 Units]
In Commercial Distribution
GS18056646500420 [Package]
Contains: 08056646500222
Package: 12.S9950.00 [25 Units]
In Commercial Distribution
GS18056646500437 [Package]
Contains: 08056646500222
Package: 12.S9539.00 [5 Units]
In Commercial Distribution
GS18056646500444 [Package]
Contains: 08056646500222
Package: 12.E0253.00 [5 Units]
In Commercial Distribution
GS18056646500451 [Package]
Contains: 08056646500222
Package: 12.E0246.00 [5 Units]
In Commercial Distribution
GS18056646500468 [Package]
Contains: 08056646500222
Package: 12.S8303.00 [10 Units]
In Commercial Distribution
GS18056646500475 [Package]
Contains: 08056646500222
Package: 12.S9184.00 [5 Units]
In Commercial Distribution
GS18056646500505 [Package]
Contains: 08056646500222
Package: 12.E0054.00 [5 Units]
In Commercial Distribution
GS18056646500512 [Package]
Contains: 08056646500222
Package: 12.S8891.00 [10 Units]
In Commercial Distribution
GS1805664650505 [Package]
Contains: 08056646500222
Package: 12.E0054.00 [5 Units]
Discontinued: 2016-12-12
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LROGeneral Surgery Tray (Kit)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-06-24
Device Publish Date2016-07-07

Devices Manufactured by OMNIA SRL

08056646509966 - Irrigation Set2024-11-19
08056646509980 - Irrigation Set2024-11-19
08052141311400 - Irrigation line, Kavo2023-08-16 Sterilizable Hose Set S600
08052141311424 - Irrigation line, Kavo2023-08-16 Hose set for Kavo INTRASurg (10/pkg)
08052141310014 - Transparent bag 67x75 cm with sliding ties for physiodispensers or for control u2023-07-06 Transparent bag 67x75 cm with sliding ties for physiodispensers or for control units
08056646505739 - Omnicover2023-07-06 Round waterproof headrest cover Ø 22 cm with elastic Shell Cover
08056646505890 - Universal seat cover and backrest cover Shell Cover2023-07-06 Universal seat cover and backrest cover Shell Cover
08056646508563 - Transparent drape 40x50 cm with adhesive tape for physiodispensers or for contro2023-07-06 Transparent drape 40x50 cm with adhesive tape for physiodispensers or for control units
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