MOLDED PRODUCTS INC.

Registration Details

Registration Name: MOLDED PRODUCTS INC.
Registration Number: 1932668
FEI Number: 1000138417
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 1812 Industrial Pkwy
City: HARLAN
State: IA
ZIP: 51537
Country: US

Regulatory Submissions

510(k) Number: K925978

Owner / Operator

Firm Name: MOLDED PRODUCTS INC.
Operator Number: 9007334
Address: 1112 CHATBURN AVE., --
City: Harlan
State: IA
Postal Code: 51537
Country: US
Correspondent: SHERI - Tyrrel

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Clamp	HXD	Class 1	General, Plastic Surgery	No	1996-08-08
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	Class 1	Clinical Chemistry	No	2010-04-14
Accessory, Surgical Apparel	LYU	Class 1	General, Plastic Surgery	No	2020-02-14
Clamp, Dialysis Arm	NOO	Class 1	Gastroenterology, Urology	No	2005-06-27
Clamp, Penile	FHA	Class 1	Gastroenterology, Urology	No	2020-11-25
Protector, Transducer, Dialysis	FIB	Class 2	Gastroenterology, Urology	No	2007-11-28
Shield, Protective, Personnel	KPY	Class 1	Radiology	No	1996-10-24
Dialyzer, Capillary, Hollow Fiber	FJI	Class 2	Gastroenterology, Urology	No	2007-11-29
Holder, Needle, Gastroenterologic	FHQ	Class 1	Gastroenterology, Urology	No	1999-08-06
Device, External Penile Rigidity	LKY	Class 2	Gastroenterology, Urology	No	2008-04-07
Set, Administration, Intravascular	FPA	Class 2	General Hospital	No	2007-11-29
Tubing, Dialysate	FID	Class 2	Gastroenterology, Urology	No	2007-11-29
Catheter, Urethral	GBM	Class 2	Gastroenterology, Urology	No	2022-01-10
Forceps	HTD	Class 1	General, Plastic Surgery	No	2013-09-20
System, Hemodialysis, Remote Accessories	MON	Class 1	Gastroenterology, Urology	No	2008-06-27
Tourniquet, Nonpneumatic	GAX	Class 1	General, Plastic Surgery	No	1999-08-06
Accessories, Blood Circuit, Hemodialysis	KOC	Class 2	Gastroenterology, Urology	No	2007-11-29
Utensil, Homemaking	IKW	Class 1	Physical Medicine	No	2010-04-14
Dialyzer Reprocessing System	LIF	Class 2	Gastroenterology, Urology	No	1994-11-30
Forceps, General & Plastic Surgery	GEN	Class 1	General, Plastic Surgery	No	1993-11-30

Proprietary Names

FISTULA PRESSURE DRESSING CLAMP, Includes MPC-260, -260B, -250, -250XL Collection Assist Device Includes MPC-745 Safety Visor & 2 Shields Includes MPC-305 FISTULA PRESSURE CLAMP 'ULTRA GRIP' COVER, Includes MPC-255 TRANSDUCER PROTECTOR, DIALYSIS, Includes MPC-80, -85 Mid-America MINI-OPT Safety Visor w/2 Shields, Includes MPC-300, -301, -302, -303. Plus Disposable Face-Shield MPC-318 Disposable Storage Caps Includes MPC-60B, -60D, -50DV, -40, -45 "ENCASE" FISTULA NEEDLE ENCAP HOLDER, Includes MPC-375 MedErect Vacuum Therapy System INJECTION LUER CAPS/PLUGS, Includes MPC-100, -124, -115, -123, -135 Re-Use/Wash-Out Lines w/connectors Includes MPC-660, -640, -720, -710, -620, -715, -650, -705, -700 Female Urethra Catheterization - Assisting Device Includes FS-1700 Plastic Thumb Forcep includes MPC-3000 Dialyzer Holder Includes MPC-1405, -1415, -1425 FISTULA PRERSSURE DRESSING STRAP/TOURNIQUET, Includes MPC-350 LUER TO LUER ADAPTER, Includes MPC-150, -155, -160 DIALYSATE TUBING W/ HANSEN CONNECTORS Includes MPC-725, -740 Male DIN to Male DIN Luer Adapter Lines Includes MPC-850, -825S, -660S, -800, -875 E-Z Grip Includes MPC-950 ASSIST HEADER CLEANER Includes MPC-50910, -50911, -50912 Tube Occluding Forceps, Plastic Hemostat and Towel Clamp Includes MPC-200, -225, -275

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)