Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016733629

FEI Number

3016733629

Entity Name

Gilero, Inc

City/State/Country

Pittsboro, NC, US

Establishment Address

158 Credle Street, Pittsboro, NC 27312, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Gilero, Inc (Owner Number: 10053703)

Owner / Operator Contact Address

4319 S. Alston Ave., Suite 100, Durham, NC 27713, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Specimen Basket Bone Basket Face Shield Speed Torque

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-06-29
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2017-01-03
QOI	Intravenous Catheter Force-Activated Separation Device.	General Hospital	Class 2	880.5220	2022-06-28
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2023-05-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-15
MLY	Vapocoolant Device	Unknown	Class U	N/A	2021-03-22
EXX	Probe, Rectal, Non-Powered	Gastroenterology, Urology	Class 1	876.4730	2023-07-20
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2021-05-12
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-07-20
QOI	Intravenous Catheter Force-Activated Separation Device.	General Hospital	Class 2	880.5220	2023-08-04
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2020-09-15
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-01-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gilero, Inc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023851856	Border Assembly S de RL de CV	TIJUANA Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016733629. Last updated year: 2026. Please use registration number 3016733629 when referencing this establishment in official correspondence.