Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010392991

FEI Number

3010392991

Entity Name

BELLUS MEDICAL, LLC

City/State/Country

Johnson City, TN, US

Establishment Address

207 Mockingbird Ln, Johnson City, TN 37604, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Bellus Medical, LLC (Owner Number: 10044925)

Owner / Operator Contact Address

207 Mockingbird Lane, Johnson City, TN 37604, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DermaFlex MicroCannula Healeon HD PRP Gold Rush PRP BTR PRP ProGen PRP Eclipse Genesis PRP SkinPen Precision Elite Boost 2+ Flex 18G X 1" Venting Needle; 30G X 1/2" Hypodermic Needle DermaFlex Aspiration Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2022-03-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-05-23
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2019-04-29
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2024-09-18
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2015-12-11
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2017-03-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-05-23
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-05-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bellus Medical, 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

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3026940910	SPOT HEALTH INC.	Cincinnati, OH, US
3020139194	LetsGetChecked Inc.	Cucamonga, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010392991. Last updated year: 2026. Please use registration number 3010392991 when referencing this establishment in official correspondence.