Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042480961

FEI Number

3042480961

Entity Name

SURGI-SERVE LLC

City/State/Country

Bloomington, IN, US

Establishment Address

4638 E State Road 45, Bloomington, IN 47408, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Surgi-Serve LLC (Owner Number: 10094704)

Owner / Operator Contact Address

4638 E SR 45, Bloomington, IN 47408, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CleanField Kit CleanField Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2025-12-17

Official Correspondent

tarek sibai

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Surgi-Serve LLC

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

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

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3007007790	Sterigenics Shanghai ETO Ltd.	Shanghai, CN
3013421458	Beaver-Visitec International, Inc.	Ciudad Juarez Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042480961. Last updated year: 2026. Please use registration number 3042480961 when referencing this establishment in official correspondence.