CUSTOMFAB, INC.

FDA Device Registration & Listing · Anaheim, CA, US · Registration 2031000

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2031000
FEI Number
3001236830
Entity Name
CUSTOMFAB, INC.
City/State/Country
Anaheim, CA, US
Establishment Address
353 N Euclid Way, Anaheim, CA 92801, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
CUSTOMFAB, INC. (Owner Number: 9029981)
Owner / Operator Contact Address
353 N. EUCLID WAY, Anaheim, CA 92801, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Gredale USA Made Level 2 Isolation Gown

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2008-05-16
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2016-03-04
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2022-07-08

Official Correspondent

Rhonda Alhanati

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CUSTOMFAB, 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
K831798 I M, Inc. DISPOSABLE SCALPELS 1983-07-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031000. Last updated year: 2026. Please use registration number 2031000 when referencing this establishment in official correspondence.
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