FDA Registration
Active
🇺🇸 United States
PRECISION DYNAMICS CORPORATION
Reg #: 2020282
·
FEI: 2020282
·
Expires 2026
Products
12
Proprietary Names
24
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- PRECISION DYNAMICS CORPORATION
- Registration Number
- 2020282
- FEI Number
- 2020282
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25124 Springfield Ct Ste 200
- City
- Valencia
- State
- CA
- ZIP
- 91355
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101598
Owner / Operator
- Firm Name
- Precision Dynamics Corporation
- Operator Number
- 2020282
- Address
- 2221 W Camden Rd
- City
- Milwaukee
- State
- WI
- Postal Code
- 53209
- Country
- US
- Correspondent
- Ami Kern
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2023-11-20 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2013-11-20 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2014-09-04 |
| Device, Paste-On For Incontinence, Non-Sterile | NOA | Class 1 | Gastroenterology, Urology | No | 2019-07-26 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2014-04-30 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2022-09-29 |
| Device, Paste-On For Incontinence, Sterile | EXI | Class 1 | Gastroenterology, Urology | No | 2019-07-26 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2011-11-30 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2014-04-30 |
| Board, Arm (With Cover), Non-Sterile | NOD | Class 1 | General, Plastic Surgery | No | 2021-10-11 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2013-11-20 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-02-22 |
Proprietary Names
C-Arm Cover, Band Bags, Footswitch Covers, C-Arm Cover Kit
Sterile Medication Labels
Surgical Skin Markers, Sterile Pens
UR-Assure Pediatric Urine Collectors, Clean Collector 05001
Spee-D-Grid
Spee-D-Grid SGRID1 SGRID2 SGRID3 SGRID-X1
Foam Cushion
Ur-Assure Pediatric Urine Collectors, Sterile 05002
Securline Umbilical Cord Clamp Clipper
Spee-D-Cool Cold Pack White Brushed Fabric
Spee-D-Cool Cold Pack, Tropical Design
Spee-D-Cool Cold Pack
Spee-D-Cool Cold Pack, Heart Shaped
Armboard, Wristboard
Left Marker, Right Marker
Spee-D-Stretch Repositionable, Spee-D-Line, Spee-D-Mark CT and MRI
Super-Sticky
Spee-D-Strip, Spee-D-Line
Radiology Skin Marker, Mammography Skin Marker
Spee-D-Mark, Spee-D-Arrow, Spee-D-Angle, Spee-D-Strip, Spee-D-Stretch
CT Scan Skin Markers, MRI Skin Markers
No Burnout, Scar Marker, Nipple Marker, Mole Marker, Ring Marker
Spee-D brand X-Ray Skin Markers
Bandage
Establishment Types
Complaint File Establishment per 21 CFR 820.198