Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1063382

FEI Number

3000718854

Entity Name

CUSTOM ASSEMBLIES, INC.

City/State/Country

PINE LEVEL, NC, US

Establishment Address

330 EAST MAIN STREET, PINE LEVEL, NC 27568, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CUSTOM ASSEMBLIES, INC. (Owner Number: 9026626)

Owner / Operator Contact Address

330 E. Main St., --, Pine Level, NC 27568, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drain Bag General Surgery Tray Needle Holder Pressure Tubing Injection Cannula Restraint Drape, Surgical Exempt Balloon Catheter Tubing, Noninvasive- CMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2023-07-20
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2013-07-08
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2021-05-11
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2016-12-07
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2021-07-28
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2016-11-18
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2021-02-03
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2016-11-18
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2012-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CUSTOM ASSEMBLIES, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

Similar Registrations

Registration Number	Establishment Name	Location
3006210673	ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD	Ningbo Zhejiang, CN
3006943846	MIRACLE MEDICAL INDUSTRIES	El Obour City Al Qahirah, EG
3016734145	CREATE BIOTECH CO., LTD.	Taoyuan City, TW
3023230882	ALPEP LLC	Orange, CA, US
3013530901	HANGZHOU ROLLMED CO.,LTD.	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063382. Last updated year: 2026. Please use registration number 1063382 when referencing this establishment in official correspondence.