SURGICAL PROCEDURE PACK
- Primary DI
- 08056646500222
- 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 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"
- Published
- 2016-07-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K110724 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08056646500529 | Package | GS1 | 30 | In Commercial Distribution |
| 08056646500536 | Package | GS1 | 15 | In Commercial Distribution |
| 08056646500543 | Package | GS1 | 10 | In Commercial Distribution |
| 08056646500550 | Package | GS1 | 10 | In Commercial Distribution |
| 08056646500567 | Package | GS1 | 10 | In Commercial Distribution |
| 08056646500574 | Package | GS1 | 6 | In Commercial Distribution |
| 08056646500581 | Package | GS1 | 6 | Not in Commercial Distribution |
| 08056646500598 | Package | GS1 | 8 | In Commercial Distribution |
| 08056646500604 | Package | GS1 | 20 | In Commercial Distribution |
| 08056646500611 | Package | GS1 | 10 | In Commercial Distribution |
| 08056646500628 | Package | GS1 | 10 | In Commercial Distribution |
| 08056646500635 | Package | GS1 | 15 | In Commercial Distribution |
| 08056646500642 | Package | GS1 | 6 | In Commercial Distribution |
| 08056646500659 | Package | GS1 | 20 | In Commercial Distribution |
| 08056646500666 | Package | GS1 | 5 | In Commercial Distribution |
| 08056646500673 | Package | GS1 | 6 | In Commercial Distribution |
| 08056646500680 | Package | GS1 | 25 | In Commercial Distribution |
| 08056646500697 | Package | GS1 | 12 | In Commercial Distribution |
| 08056646500703 | Package | GS1 | 6 | In Commercial Distribution |
| 08056646500710 | Package | GS1 | 8 | In Commercial Distribution |
| 08056646500727 | Package | GS1 | 20 | In Commercial Distribution |
| 08056646500734 | Package | GS1 | 6 | In Commercial Distribution |
| 08056646500758 | Package | GS1 | 8 | In Commercial Distribution |
| 08056646500765 | Package | GS1 | 10 | In Commercial Distribution |
| 08056646500772 | Package | GS1 | 40 | In Commercial Distribution |
| 08056646500789 | Package | GS1 | 8 | In Commercial Distribution |
| 08056646500796 | Package | GS1 | 5 | In Commercial Distribution |
| 08056646500802 | Package | GS1 | 8 | In Commercial Distribution |
| 08056646500819 | Package | GS1 | 15 | In Commercial Distribution |
| 08056646500826 | Package | GS1 | 2 | In Commercial Distribution |
| 80566465000505 | Package | GS1 | 5 | Not in Commercial Distribution |
| 8056646500239 | Package | GS1 | 6 | In Commercial Distribution |
| 8056646500246 | Package | GS1 | 6 | In Commercial Distribution |
| 8056646500253 | Package | GS1 | 6 | In Commercial Distribution |
| 8056646500260 | Package | GS1 | 6 | In Commercial Distribution |
| 8056646500277 | Package | GS1 | 6 | In Commercial Distribution |
| 8056646500284 | Package | GS1 | 10 | In Commercial Distribution |
| 8056646500291 | Package | GS1 | 10 | In Commercial Distribution |
| 8056646500307 | Package | GS1 | 6 | In Commercial Distribution |
| 8056646500314 | Package | GS1 | 6 | In Commercial Distribution |
| 8056646500321 | Package | GS1 | 1 | In Commercial Distribution |
| 8056646500338 | Package | GS1 | 1 | In Commercial Distribution |
| 8056646500345 | Package | GS1 | 6 | In Commercial Distribution |
| 8056646500352 | Package | GS1 | 6 | In Commercial Distribution |
| 8056646500369 | Package | GS1 | 5 | In Commercial Distribution |
| 8056646500376 | Package | GS1 | 8 | In Commercial Distribution |
| 8056646500383 | Package | GS1 | 2 | In Commercial Distribution |
| 8056646500390 | Package | GS1 | 50 | In Commercial Distribution |
| 8056646500406 | Package | GS1 | 20 | In Commercial Distribution |
| 8056646500413 | Package | GS1 | 100 | In Commercial Distribution |
| 8056646500420 | Package | GS1 | 25 | In Commercial Distribution |
| 8056646500437 | Package | GS1 | 5 | In Commercial Distribution |
| 8056646500444 | Package | GS1 | 5 | In Commercial Distribution |
| 8056646500451 | Package | GS1 | 5 | In Commercial Distribution |
| 8056646500468 | Package | GS1 | 10 | In Commercial Distribution |
| 8056646500475 | Package | GS1 | 5 | In Commercial Distribution |
| 8056646500505 | Package | GS1 | 5 | In Commercial Distribution |
| 8056646500512 | Package | GS1 | 10 | In Commercial Distribution |
| 805664650505 | Package | GS1 | 5 | Not in Commercial Distribution |
| 08056646500222 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 08056646500529 | 08056646500529 | 8056646500529 | |
| 08056646500536 | 08056646500536 | 8056646500536 | |
| 08056646500543 | 08056646500543 | 8056646500543 | |
| 08056646500550 | 08056646500550 | 8056646500550 | |
| 08056646500567 | 08056646500567 | 8056646500567 | |
| 08056646500574 | 08056646500574 | 8056646500574 | |
| 08056646500581 | 08056646500581 | 8056646500581 | |
| 08056646500598 | 08056646500598 | 8056646500598 | |
| 08056646500604 | 08056646500604 | 8056646500604 | |
| 08056646500611 | 08056646500611 | 8056646500611 | |
| 08056646500628 | 08056646500628 | 8056646500628 | |
| 08056646500635 | 08056646500635 | 8056646500635 | |
| 08056646500642 | 08056646500642 | 8056646500642 | |
| 08056646500659 | 08056646500659 | 8056646500659 | |
| 08056646500666 | 08056646500666 | 8056646500666 | |
| 08056646500673 | 08056646500673 | 8056646500673 | |
| 08056646500680 | 08056646500680 | 8056646500680 | |
| 08056646500697 | 08056646500697 | 8056646500697 | |
| 08056646500703 | 08056646500703 | 8056646500703 | |
| 08056646500710 | 08056646500710 | 8056646500710 | |
| 08056646500727 | 08056646500727 | 8056646500727 | |
| 08056646500734 | 08056646500734 | 8056646500734 | |
| 08056646500758 | 08056646500758 | 8056646500758 | |
| 08056646500765 | 08056646500765 | 8056646500765 | |
| 08056646500772 | 08056646500772 | 8056646500772 | |
| 08056646500789 | 08056646500789 | 8056646500789 | |
| 08056646500796 | 08056646500796 | 8056646500796 | |
| 08056646500802 | 08056646500802 | 8056646500802 | |
| 08056646500819 | 08056646500819 | 8056646500819 | |
| 08056646500826 | 08056646500826 | 8056646500826 | |
| 80566465000505 | 80566465000505 | ||
| 8056646500239 | 08056646500239 | 8056646500239 | |
| 8056646500246 | 08056646500246 | 8056646500246 | |
| 8056646500253 | 08056646500253 | 8056646500253 | |
| 8056646500260 | 08056646500260 | 8056646500260 | |
| 8056646500277 | 08056646500277 | 8056646500277 | |
| 8056646500284 | 08056646500284 | 8056646500284 | |
| 8056646500291 | 08056646500291 | 8056646500291 | |
| 8056646500307 | 08056646500307 | 8056646500307 | |
| 8056646500314 | 08056646500314 | 8056646500314 | |
| 8056646500321 | 08056646500321 | 8056646500321 | |
| 8056646500338 | 08056646500338 | 8056646500338 | |
| 8056646500345 | 08056646500345 | 8056646500345 | |
| 8056646500352 | 08056646500352 | 8056646500352 | |
| 8056646500369 | 08056646500369 | 8056646500369 | |
| 8056646500376 | 08056646500376 | 8056646500376 | |
| 8056646500383 | 08056646500383 | 8056646500383 | |
| 8056646500390 | 08056646500390 | 8056646500390 | |
| 8056646500406 | 08056646500406 | 8056646500406 | |
| 8056646500413 | 08056646500413 | 8056646500413 | |
| 8056646500420 | 08056646500420 | 8056646500420 | |
| 8056646500437 | 08056646500437 | 8056646500437 | |
| 8056646500444 | 08056646500444 | 8056646500444 | |
| 8056646500451 | 08056646500451 | 8056646500451 | |
| 8056646500468 | 08056646500468 | 8056646500468 | |
| 8056646500475 | 08056646500475 | 8056646500475 | |
| 8056646500505 | 08056646500505 | 8056646500505 | |
| 8056646500512 | 08056646500512 | 8056646500512 | |
| 805664650505 | 00805664650505 | 805664650505 | 0805664650505 |
| 08056646500222 | 08056646500222 | 8056646500222 |
GMDN Terms#
| Term | Definition |
|---|---|
| General surgical procedure kit, non-medicated, single-use | A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device. |
Contacts#
| Phone | |
|---|---|
| +390524527453 | info@omniaspa.eu |
Regulatory Flags#
- DUNS number
- 447696675
- Device count
- 1
- Combination product
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08052141311806 | Irrigation Line | 32.F0139.00 | 2026-03-27 | |
| 08052141312025 | Irrigation Line | 32.F0170.00 | 2026-03-27 | |
| 08052141312780 | Irrigation Line | 32.F0006.00 | 2026-03-27 | |
| 08052141312865 | Irrigation Line | 32.F0134.00 | 2026-03-27 | |
| 08052141312940 | Irrigation Line | 32.F0161.00 | 2026-03-27 | |
| 08052141313602 | Irrigation Line | 32.F0105.00 | 2026-03-27 | |
| 08056646500291 | Basic Implant Set | 12.S5621.00 | 2026-03-27 | |
| 08056646500307 | Implantology Set | 12.S4671.00 | 2026-03-27 | |
| 08056646500321 | Oral Surgery Set | 12.S4096.00 | 2026-03-27 | |
| 08056646500482 | Oral Surgery Pack | 12.S8318.00 | 2026-03-27 | |
| 08056646508846 | Adhesive Films | 32.U0020.00 | 2026-03-27 | |
| 08056646508945 | Adhesive Films | 32.U4020.00 | 2026-03-27 | |
| 08056646503018 | Sterile PTFE Surgical Suture | 32.Z4400.00 | 2017-02-27 | |
| 08056646500017 | Sterile PTFE Surgical Suture | 32.Z3130.00 | 2016-05-31 | |
| 08056646500031 | Sterile PTFE Surgical Suture | 32.Z3141.00 | 2016-07-07 | |
| 08056646500055 | Sterile PTFE Surgical Suture | 32.Z3150.00 | 2016-08-29 | |
| 08056646500079 | Sterile PTFE Surgical Suture | 32.Z3160.00 | 2016-08-29 | |
| 08056646500086 | Sterile PTFE Surgical Suture | 32.Z3151.00 | 2016-08-29 | |
| 08056646500116 | Sterile PTFE Surgical Suture | 32.Z3260.00 | 2016-08-29 | |
| 08056646500123 | Sterile PTFE Surgical Suture | 32.Z3240.00 | 2016-08-29 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10653160393702 | MEDLINE | MEDLINE INDUSTRIES, INC. | LRO | 2026-05-27 |
| 10653160393757 | CENTURION | CENTURION MEDICAL PRODUCTS CORPORATION | LRO | 2026-05-27 |
| 10809160521878 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160521885 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160521892 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160521922 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160521939 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160521946 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160521953 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160521960 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160521977 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160521991 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160522004 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160522011 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 10809160522028 | Halyard | AVID MEDICAL, INC. | LRO | 2026-05-27 |
| 08056646500291 | Basic Implant Set | OMNIA SRL | KKX | 2026-03-27 |
| 08056646500307 | Implantology Set | OMNIA SRL | KKX | 2026-03-27 |
| 08056646500321 | Oral Surgery Set | OMNIA SRL | KKX | 2026-03-27 |
| 08056646500482 | Oral Surgery Pack | OMNIA SRL | KKX | 2026-03-27 |
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