Irrigation Line - Hose Set for machinery irrigation system to be used with dispensing liquid coolants in oral surgery
2026-03-27
OMNIA SRL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004361903 | 3004361903 | OMNIA SRL | 1 | N | 2026-01-01 | VIA F.DELNEVO 190 FIDENZA Parma IT 43036 |
| 3011710821 | 3011710821 | OMNIA SRL | 1 | N | 2026-01-01 | Via A. Volta, 7 Mirandola Modena IT 41037 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 22450 | 1115134129 | K911334 | MASK, SURGICAL APPAREL | FXX | 1991-08-29 |
| 22450 | 1325053555 | K180630 | PTFE SURGICAL SUTURE | NBY | 2018-04-06 |
| 22450 | 1552105919 | K132464 | PTFE SURGICAL SUTURE | NBY | 2014-02-12 |
| 22450 | 1276554599 | K110724 | SURGICAL PROCEDURE PACKS | FYA | 2011-06-23 |
| 22450 | 1390856062 | ||||
| 22450 | 1516182363 | ||||
| 22450 | 1093021301 | ||||
| 22450 | 1179063565 | ||||
| 22450 | 1235212358 | ||||
| 22450 | 1244901006 | ||||
| 22450 | 1266567774 | ||||
| 22450 | 1284082379 | ||||
| 22450 | 1291486023 | ||||
| 296762 | 1390856062 | ||||
| 22450 | 1472425923 | ||||
| 22450 | 1475893887 | ||||
| 22450 | 1552561137 | ||||
| 296762 | 1552561137 | ||||
| 22450 | 1582064045 | ||||
| 22450 | 1619525852 | ||||
| 296762 | 1694293791 | ||||
| 22450 | 1694293791 | ||||
| 22450 | 1775323935 | ||||
| 22450 | 1782577793 | ||||
| 22450 | 1838957454 | ||||
| 296762 | 1847678951 | ||||
| 22450 | 1854347591 | ||||
| 22450 | 1954125783 | ||||
| 22450 | 2008599365 | ||||
| 296762 | 2041680168 | ||||
| 22450 | 2064990734 |
Product Codes Associated With Registrations#
GUDID#
Irrigation Line - Hose Set for machinery irrigation system to be used with dispensing liquid coolants in oral surgery
2026-03-27
Irrigation Line - Hose Set for machinery irrigation system to be used with dispensing liquid coolants in oral surgery
2026-03-27
Irrigation Line - Hose Set for machinery irrigation system to be used with dispensing liquid coolants in oral surgery
2026-03-27
Irrigation Line - Hose Set for machinery irrigation system to be used with dispensing liquid coolants in oral surgery
2026-03-27
Irrigation Line - Hose Set for machinery irrigation system to be used with dispensing liquid coolants in oral surgery
2026-03-27
Basic Implant Set - 12.S5621.00
2026-03-27
Implantology Set - 12.S4671.00
2026-03-27
Oral Surgery Set - 12.S4096.00
2026-03-27
Oral Surgery Pack - 12.S8318.00
2026-03-27
Adhesive Films - 10 Sterile Blisters of 5 Adhesive Films (20x20 cm) – 2 CROSS20 – Light Blue
2026-03-27
Adhesive Films - 10 Sterile Blisters of 5 adhesive films 17X26 cm Transparent
2026-03-27
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 3/0 - 19 mm Needle 3/8 - Body Reverse Cutting
2017-02-27
Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 3/0 - 19 mm 3/8 Needle - Body Reverse Cutting
2016-05-31
Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 4/0 - 16 mm 3/8 Needle - Body Reverse Cutting
2016-07-07
Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 5/0 - 12 mm 1/2 Needle - Body Reverse Cutting
2016-08-29
Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 6/0 - 11 mm 1/2 Needle - Body Reverse Cutting
2016-08-29
Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 5/0 -12 mm Needle 3/8 - Body Reverse Cutting
2016-08-29
Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 6/0 - Diamond tip 10 mm Needle 1/2 - Round Body
2016-08-29
Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 4/0 - Diamond tip 18 mm Needle 3/8 - Round Body
2016-08-29
Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 5/0 - Diamond tip 18 mm Needle 3/8 - Round Body
2016-08-29
Sterile PTFE Surgical Suture - PTFE Suture 75 cm - 5/0 - Extra Cutting tip - 12 mm Needle 3/8 - Extra Reverse Cutting
2017-03-01
Sterile PTFE Surgical Suture - PTFE Suture 45 cm - 6/0 - Extra Cutting tip - 10 mm Needle 3/8 - Body Reverse Cutting
2016-11-29
Sterile PTFE Surgical Suture - PTFE Suture 45 cm - 7/0 - Extra Cutting tip - 10 mm Needle 3/8 - Reverse Cutting
2017-03-01
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 4/0 - 16 mm Needle 3/8 - Body Reverse Cutting
2017-02-27
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 5/0 - 12 mm Needle 1/2 - Body Reverse Cutting
2017-02-27
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 5/0 - 12 mm Needle 3/8 - Body Reverse Cutting
2017-02-27
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 4/0 - Diamond tip 18 mm Needle 3/8 - Round Body
2017-02-27
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 5/0 - Diamond tip 18 mm Needle 3/8 - Round Body
2017-02-27
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 6/0 - Diamond tip 11 mm Needle 1/2 - Round Body
2017-02-27
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 6/0 - Diamond tip 10 mm Needle 1/2 - Round Body
2017-02-27
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 6/0 - 12 mm Needle 3/8 - Body Reverse Cutting
2017-02-27
Sterile PTFE Surgical Suture - PTFE Suture 60 cm - 5/0 - Extra Cutting tip - 12 mm Needle 3/8 - Body Reverse Cutting
2017-02-27
FACE MASKS - 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - GREEN
2016-08-30
FACE MASKS - 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - BLUE
2016-08-30
FACE MASKS - 3-LAYER FACE MASK WITH STRINGS - LIGHT BLUE
2016-08-30
FACE MASKS - 3-LAYER FACE MASK WITH STRINGS - LIGHT GREEN
2016-08-30
FACE MASKS - 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - WITH PRINTING
2016-08-30
FACE MASKS - 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - ORANGE
2016-08-30
FACE MASKS - 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - PURPLE
2016-08-30