SURGICAL PROCEDURE PACK

Primary DI
8056646500239
Brand
SURGICAL PROCEDURE PACK
Company
OMNIA SRL
Model
12.XYYYY.00
Device description
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
Published
2016-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray (Kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110724000SURGICAL PROCEDURE PACKSOmnia Spa2011-06-23FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056646500529PackageGS130In Commercial Distribution
08056646500536PackageGS115In Commercial Distribution
08056646500543PackageGS110In Commercial Distribution
08056646500550PackageGS110In Commercial Distribution
08056646500567PackageGS110In Commercial Distribution
08056646500574PackageGS16In Commercial Distribution
08056646500581PackageGS16Not in Commercial Distribution
08056646500598PackageGS18In Commercial Distribution
08056646500604PackageGS120In Commercial Distribution
08056646500611PackageGS110In Commercial Distribution
08056646500628PackageGS110In Commercial Distribution
08056646500635PackageGS115In Commercial Distribution
08056646500642PackageGS16In Commercial Distribution
08056646500659PackageGS120In Commercial Distribution
08056646500666PackageGS15In Commercial Distribution
08056646500673PackageGS16In Commercial Distribution
08056646500680PackageGS125In Commercial Distribution
08056646500697PackageGS112In Commercial Distribution
08056646500703PackageGS16In Commercial Distribution
08056646500710PackageGS18In Commercial Distribution
08056646500727PackageGS120In Commercial Distribution
08056646500734PackageGS16In Commercial Distribution
08056646500758PackageGS18In Commercial Distribution
08056646500765PackageGS110In Commercial Distribution
08056646500772PackageGS140In Commercial Distribution
08056646500789PackageGS18In Commercial Distribution
08056646500796PackageGS15In Commercial Distribution
08056646500802PackageGS18In Commercial Distribution
08056646500819PackageGS115In Commercial Distribution
08056646500826PackageGS12In Commercial Distribution
80566465000505PackageGS15Not in Commercial Distribution
8056646500239PackageGS16In Commercial Distribution
8056646500246PackageGS16In Commercial Distribution
8056646500253PackageGS16In Commercial Distribution
8056646500260PackageGS16In Commercial Distribution
8056646500277PackageGS16In Commercial Distribution
8056646500284PackageGS110In Commercial Distribution
8056646500291PackageGS110In Commercial Distribution
8056646500307PackageGS16In Commercial Distribution
8056646500314PackageGS16In Commercial Distribution
8056646500321PackageGS11In Commercial Distribution
8056646500338PackageGS11In Commercial Distribution
8056646500345PackageGS16In Commercial Distribution
8056646500352PackageGS16In Commercial Distribution
8056646500369PackageGS15In Commercial Distribution
8056646500376PackageGS18In Commercial Distribution
8056646500383PackageGS12In Commercial Distribution
8056646500390PackageGS150In Commercial Distribution
8056646500406PackageGS120In Commercial Distribution
8056646500413PackageGS1100In Commercial Distribution
8056646500420PackageGS125In Commercial Distribution
8056646500437PackageGS15In Commercial Distribution
8056646500444PackageGS15In Commercial Distribution
8056646500451PackageGS15In Commercial Distribution
8056646500468PackageGS110In Commercial Distribution
8056646500475PackageGS15In Commercial Distribution
8056646500505PackageGS15In Commercial Distribution
8056646500512PackageGS110In Commercial Distribution
805664650505PackageGS15Not in Commercial Distribution
08056646500222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
08056646500529080566465005298056646500529
08056646500536080566465005368056646500536
08056646500543080566465005438056646500543
08056646500550080566465005508056646500550
08056646500567080566465005678056646500567
08056646500574080566465005748056646500574
08056646500581080566465005818056646500581
08056646500598080566465005988056646500598
08056646500604080566465006048056646500604
08056646500611080566465006118056646500611
08056646500628080566465006288056646500628
08056646500635080566465006358056646500635
08056646500642080566465006428056646500642
08056646500659080566465006598056646500659
08056646500666080566465006668056646500666
08056646500673080566465006738056646500673
08056646500680080566465006808056646500680
08056646500697080566465006978056646500697
08056646500703080566465007038056646500703
08056646500710080566465007108056646500710
08056646500727080566465007278056646500727
08056646500734080566465007348056646500734
08056646500758080566465007588056646500758
08056646500765080566465007658056646500765
08056646500772080566465007728056646500772
08056646500789080566465007898056646500789
08056646500796080566465007968056646500796
08056646500802080566465008028056646500802
08056646500819080566465008198056646500819
08056646500826080566465008268056646500826
8056646500050580566465000505
8056646500239080566465002398056646500239
8056646500246080566465002468056646500246
8056646500253080566465002538056646500253
8056646500260080566465002608056646500260
8056646500277080566465002778056646500277
8056646500284080566465002848056646500284
8056646500291080566465002918056646500291
8056646500307080566465003078056646500307
8056646500314080566465003148056646500314
8056646500321080566465003218056646500321
8056646500338080566465003388056646500338
8056646500345080566465003458056646500345
8056646500352080566465003528056646500352
8056646500369080566465003698056646500369
8056646500376080566465003768056646500376
8056646500383080566465003838056646500383
8056646500390080566465003908056646500390
8056646500406080566465004068056646500406
8056646500413080566465004138056646500413
8056646500420080566465004208056646500420
8056646500437080566465004378056646500437
8056646500444080566465004448056646500444
8056646500451080566465004518056646500451
8056646500468080566465004688056646500468
8056646500475080566465004758056646500475
8056646500505080566465005058056646500505
8056646500512080566465005128056646500512
805664650505008056646505058056646505050805664650505
08056646500222080566465002228056646500222

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390524527453info@omniaspa.eu

Regulatory Flags#

DUNS number
447696675
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052141311806Irrigation Line32.F0139.002026-03-27
08052141312025Irrigation Line32.F0170.002026-03-27
08052141312780Irrigation Line32.F0006.002026-03-27
08052141312865Irrigation Line32.F0134.002026-03-27
08052141312940Irrigation Line32.F0161.002026-03-27
08052141313602Irrigation Line32.F0105.002026-03-27
08056646500291Basic Implant Set12.S5621.002026-03-27
08056646500307Implantology Set12.S4671.002026-03-27
08056646500321Oral Surgery Set12.S4096.002026-03-27
08056646500482Oral Surgery Pack12.S8318.00 2026-03-27
08056646508846Adhesive Films32.U0020.002026-03-27
08056646508945Adhesive Films32.U4020.002026-03-27
08056646503018Sterile PTFE Surgical Suture32.Z4400.002017-02-27
08056646500017Sterile PTFE Surgical Suture32.Z3130.002016-05-31
08056646500031Sterile PTFE Surgical Suture32.Z3141.002016-07-07
08056646500055Sterile PTFE Surgical Suture32.Z3150.002016-08-29
08056646500079Sterile PTFE Surgical Suture32.Z3160.002016-08-29
08056646500086Sterile PTFE Surgical Suture32.Z3151.002016-08-29
08056646500116Sterile PTFE Surgical Suture32.Z3260.002016-08-29
08056646500123Sterile PTFE Surgical Suture32.Z3240.002016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160393702MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-05-27
10653160393757CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-05-27
10809160521878HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521885HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521892HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521922HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521939HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521946HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521953HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521960HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521977HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521991HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522004HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522011HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522028HalyardAVID MEDICAL, INC.LRO2026-05-27
H65857028265Henry ScheinHENRY SCHEIN, INC.LRO2022-01-28
H65857028255Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028285Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028925Henry ScheinHENRY SCHEIN, INC.LRO2022-01-26
H65857028935Henry ScheinHENRY SCHEIN, INC.LRO2022-01-25
H65857028945Henry ScheinHENRY SCHEIN, INC.LRO2022-01-25
H65857028915Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028965Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028975Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028985Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028905Henry ScheinHENRY SCHEIN, INC.LRO2022-01-18
H65857028875Henry ScheinHENRY SCHEIN, INC.LRO2021-12-29
H65857028865Henry ScheinHENRY SCHEIN, INC.LRO2021-12-21
H65857028855Henry ScheinHENRY SCHEIN, INC.LRO2021-12-14
H65857028845Henry ScheinHENRY SCHEIN, INC.LRO2021-12-13