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 |
|---|---|
| LRO | General Surgery Tray (Kit) |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LRO | General Surgery Tray | General, Plastic Surgery | 2 |
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/plastic surgical procedure kit, non-medicated, single-use | A 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 |
|---|
Contacts#
| Phone | |
|---|---|
| +390524527453 | info@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 | 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 |
| H65857028265 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-28 |
| H65857028255 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-27 |
| H65857028285 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-27 |
| H65857028925 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-26 |
| H65857028935 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-25 |
| H65857028945 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-25 |
| H65857028915 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-24 |
| H65857028965 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-24 |
| H65857028975 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-24 |
| H65857028985 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-24 |
| H65857028905 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2022-01-18 |
| H65857028875 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2021-12-29 |
| H65857028865 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2021-12-21 |
| H65857028855 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2021-12-14 |
| H65857028845 | Henry Schein | HENRY SCHEIN, INC. | LRO | 2021-12-13 |