FDA Registration
Active
🇺🇸 United States
KS-62030
Reg #: 1226188
·
FEI: 3008342029
·
Expires 2025
Products
1
Proprietary Names
96
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OMNIlifeScience, Inc.
- Registration Number
- 1226188
- FEI Number
- 3008342029
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 480 Paramount Dr
- City
- Raynham
- State
- MA
- ZIP
- 02767
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231172
Owner / Operator
- Firm Name
- OMNI Life Science, Inc.
- Operator Number
- 9038042
- Address
- 480 Paramount Drive
- City
- Raynham
- State
- MA
- Postal Code
- 02767
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-01-28 |
Proprietary Names
KS-62030
TKR.IN.1700
NS-5034B
NS-300G4
TKR.BB.1704
NS-5033B
NS-40100
TKR.IN02A
NS-5054A
TKR.BB.1400
TKR.IN.1850
NS-5031B
4145-1030
TKR.BB.1103
NS-40300
TKR.IN.1400
COR.TS.1300
NS-5054B
TKR.OB.1201
TKR.BB.1402
NS-40130
TKR.BB.1102
COR.TS.1700
TKR.BB.1101
NS-5035B
COR.TS.1500
TKR.BB.1703
4145-5004
TKR.BB.1450
NS-5036A
NS-5035A
4144-8000
NS-5055A
NS-5056B
TKR.IN.1351
TKR.BB.1707
4145-5003
4148-1004
4148-1001
TKR.BB.1700
TKR.IN004
TKR.OB.2000
NS-5033A
NS-5031A
TKR.OB.1400
TKR.BB.1702
NS-5058B
TKR.OB.1900
TKR.BB.1200
4149-5000
4137-5050
TKR.BB.1701
TKR.IN005
NS-5032A
TKR.IN.1342
TKR.IN001
NS-5055B
TKR.BB.1401
TKR.BB.1705
TKR.IN02U
TKR.KT.1300
NS-5053B
COR.TS.1800
COR.TS.1600
NS-5057A
NS-300P4
TKR.IN.1352
NS-5036B
NS-5053A
TKR.IN.1331
NS-300F4
NS-5058A
TKR.BB.1100
TKR.OB.1300
TKR.OB.1200
TKR.BB.1403
NS-5034A
NS-5056A
4148-1005
COR.TS.1900
TKR.IN003
TKR.BB.1500
TKR.OB.1350
NS-40150
NS-300T4
TKR.BB.1706
TKR.IN.1341
TKR.OB.1150
TKR.IN.1600
4154-5000
NS-5032B
TKR.IN.1332
4148-1002
TKR.IN.1800
4137-2050
NS-5057B
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)