FDA Registration
Active
🇺🇸 United States
RLS Interventional Inc. DBA Inrad
Reg #: 1835568
·
FEI: 3001237677
·
Expires 2026
Products
7
Proprietary Names
86
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- RLS Interventional Inc. DBA Inrad
- Registration Number
- 1835568
- FEI Number
- 3001237677
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4375 Donkers Ct SE
- City
- Grand Rapids
- State
- MI
- ZIP
- 49512
- Country
- US
Regulatory Submissions
- 510(k) Number
- K000612
Owner / Operator
- Firm Name
- INRAD
- Operator Number
- 9031756
- Address
- 4375 DONKER COURT S.E., --
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49512
- Country
- US
- Correspondent
- Heidi - Halverson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2024-01-11 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2024-01-11 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2019-11-15 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-12-06 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2007-12-06 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2014-07-03 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2012-10-30 |
Proprietary Names
AccuCore
18G x 15cm, 20mm PreciseCore Biopsy Device
20G x 10cm, 10mm PreciseCore Biopsy Device
18G x 5cm, 20mm PreciseCore Biopsy Device
20G x 5cm, 10mm PreciseCore Biopsy Device
18G x 10cm, 10mm PreciseCore Biopsy Device
14G x 5cm, 20mm PreciseCore Biopsy Device
14G x 10cm, 10mm PreciseCore Biopsy Device
20G x 5cm, 20mm PreciseCore Biopsy Device
14G x 5cm, 10mm PreciseCore Biopsy Device
18G x 5cm, 10mm PreciseCore Biopsy Device
20G x 15cm, 20mm PreciseCore Biopsy Device
18G x 10cm, 20mm PreciseCore Biopsy Device
20G x 10cm, 20mm PreciseCore Biopsy Device
14G x 10cm, 20mm PreciseCore Biopsy Device
Aspiration Biopsy Syringe Gun
Coaxial Introducer Needles
18G x 10cm SelectCore Variable Throw Biopsy Device
18G x 15cm SelectCore Variable Throw Biopsy Device
20G x 10cm SelectCore Variable Throw Biopsy Device
20G x 15cm SelectCore Variable Throw Biopsy Device
14G x 15cm SelectCore Variable Throw Biopsy Device
14G x 10cm SelectCore Variable Throw Biopsy Device
20G x 20cm SelectCore Variable Throw Biopsy Device
18G x 20cm SelectCore Variable Throw Biopsy Device
EasyMark Tissue Marker
ExpressCore Core Biopsy Device
18G x 5.4cm (2.125 inch) Modified Cournand 2-Part Introducer
18G x 5.4cm (2.125 inch) Cournand 2-Part Introducer
IV Decanter
23G x 5.1cm (2 inch) ProcytinTM Coated Aspiration Needle
25G x 3.8cm (1.5 inch) Procytin Coated Aspiration Needle
AccuPlaceTM Straight Level Needle Guide
AccuPlace Round Level Needle Guide
19G x 7cm (2.75 inch) Seldinger 2-Part Introducer
18G x 7cm (2.75 inch) Seldinger 2-Part Introducer
18G x 7cm (2.75 inch) Flashback 1-Part Introducer
19G x 7cm (2.75 inch) Arterial 1-Part Introducer
18G x 7.3cm (2.875 inch) Seldinger 2-Part Introducer
18G x 7cm (2.75 inch) Arterial 1-Part Introducer
19G x 10cm (3.94 inch) Seldinger 2-Part Introducer
19G x 7cm (2.75 inch) Flashback 1-Part Introducer
22G x 14.9cm Franseen with 19G x 10cm Coaxial Needle
22G x 14.9cm Chiba with 19G x 10cm Coaxial Needle
20G x 20cm (7.875 inch) Franseen Needle with AccuMark Sheath
20G x 20cm (7.875 inch) Chiba Needle
22G x 9.8cm (3.875 inch) Chiba Needle with AccuMark Sheath
20G x 9.8cm (3.875 inch) SampleMaster Chiba Needle
20G x 14.9cm (5.875 inch) Chiba Needle with AccuMark Sheath
20G x 20cm (7.875 inch) Franseen Needle
20G x 14.9cm (5.875 inch) SampleMaster Franseen Needle with HiLiter Tip
22G x 14.9cm (5.875 inch) Chiba Needle
22G x 9.8cm (3.875 inch) SampleMaster Chiba Needle with HiLiter Tip
20G x 9.8cm (3.875 inch) SampleMaster Chiba Needle with HiLiter Tip
18G x 20cm (7.875 inch) Chiba Needle with AccuMark Sheath
22G x 6cm (2.350 inch) SampleMaster Sharp Bevel Needle with HiLiter Tip
18G x 6cm (2.350 inch) SampleMaster Chiba Needle with HiLiter Tip
20G x 14.9cm (5.875 inch) Franseen Needle
22G x 9.8cm (3.875 inch) Chiba Needle
20G x 6cm (2.350 inch) SampleMaster Chiba Needle with HiLiter Tip
22G x 14.9cm (5.875 inch) Franseen Needle with AccuMark Sheath
20G x 14.9cm (5.875 inch) Chiba Needle
18G x 14.9cm (5.875 inch) Chiba Needle with AccuMark Sheath
22G x 9.8cm (3.875 inch) SampleMaster Chiba Needle
22G x 14.9cm (5.875 inch) SampleMaster Chiba Needle
22G x 20cm (7.875 inch) Chiba Needle
18G x 6cm (2.350 inch) SampleMaster Sharp Bevel Needle with HiLiter Tip
22G x 14.9cm (5.875 inch) SampleMaster Chiba Needle with HiLiter Tip
22G x 20cm (7.875 inch) SampleMaster Chiba Needle with HiLiter Tip
18G x 14.9cm (5.875 inch) SampleMaster Chiba Needle with HiLiter Tip
20G x 14.9cm (5.875 inch) Franseen Needle with AccuMark Sheath
22G x 14.9cm (5.875 inch) Chiba Needle with AccuMark Sheath
20G x 6cm (2.350 inch) SampleMaster Sharp Bevel Needle with HiLiter Tip
20G x 14.9cm (5.875 inch) SampleMaster Chiba Needle with HiLiter Tip
22G x 20cm (7.875 inch) Chiba Needle with AccuMark Sheath
18G x 20cm (7.875 inch) Franseen Needle
18G x 14.9cm (5.875 inch) Chiba Needle
18G x 20cm (7.875 inch) Chiba Needle
18G x 14.9cm (5.875 inch) SampleMaster Chiba Needle
20G x 20cm (7.875 inch) Chiba Needle with AccuMark Sheath
22G x 20cm (7.875 inch) Franseen Needle
22G x 20cm (7.875 inch) SampleMaster Chiba Needle
20G x 14.9cm (5.875 inch) SampleMaster Chiba Needle
22G x 6cm (2.350 inch) SampleMaster Chiba Needle with HiLiter Tip
22G x 14.9cm (5.875 inch) SampleMaster Franseen Needle with HiLiter Tip
Trilogy Tissue Marker Device
Establishment Types
Manufacture Medical Device