Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2020282

FEI Number

2020282

Entity Name

PRECISION DYNAMICS CORPORATION

City/State/Country

Valencia, CA, US

Establishment Address

25124 Springfield Ct Ste 200, Valencia, CA 91355, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Precision Dynamics Corporation (Owner Number: 2020282)

Owner / Operator Contact Address

2221 W Camden Rd, Milwaukee, WI 53209, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2023-11-20
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2013-11-20
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2014-09-04
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2019-07-26
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2014-04-30
LWG	Surgical Table Cushion	General, Plastic Surgery	Class 1	878.4950	2022-09-29
EXI	Device, Paste-On For Incontinence, Sterile	Gastroenterology, Urology	Class 1	876.5250	2019-07-26
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2011-11-30
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2014-04-30
NOD	Board, Arm (With Cover), Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2021-10-11
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2013-11-20

Official Correspondent

Ami Kern

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision Dynamics Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011859755	Brady (Xiamen) Co. Ltd.	Xiamen Fujian, CN
3006079533	W. H. Brady S. de R.L. de C.V.	Tijuana Baja California, MX
3003450039	Brady Worldwide	Milwaukee, WI, US
3010790521	Brady Mexico, S. de R.L. de C.V.	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

Similar Registrations

Registration Number	Establishment Name	Location
3030954512	MMI NORTH AMERICA, INC.	Jacksonville, FL, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
2022435	Sterigenics U.S., LLC	Tustin, CA, US
2648727	CUSTOMED, INC.	Fajardo, PR, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2020282. Last updated year: 2026. Please use registration number 2020282 when referencing this establishment in official correspondence.