Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1055892

FEI Number

1000111202

Entity Name

SRI Healthcare, LLC

City/State/Country

MEBANE, NC, US

Establishment Address

1416 DOGWOOD WAY, MEBANE, NC 27302, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SRI Healthcare, LLC (Owner Number: 10054706)

Owner / Operator Contact Address

5155 Westpark Dr. SW, Atlanta, GA 30336, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Novo Health Services SRI Healthcare, LLC SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC Novo Health Services Novo Health Services SRI Healthcare, LLC SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC Novo Health Services Novo Health Services SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC Novo Health Services SRI Healthcare, LLC SRI Healthcare, LLC Novo Health Services Novo Health Services SRI Healthcare, LLC SRI Healthcare, LLC Novo Health Services

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-03-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-08-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-08-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-01-28
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2018-08-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-08-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-09-05
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2017-04-17
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2021-04-13
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2017-04-17
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-03-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-09-05
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2018-09-05
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2018-08-30

Official Correspondent

Rebecca Cox

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SRI Healthcare, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1055954	SRI Healthcare, LLC	ATL, GA, US
1065597	SRI Healthcare, LLC	CHATTANOOGA, TN, US
1527607	SRI Healthcare, LLC	MASON, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Similar Registrations

Registration Number	Establishment Name	Location
3030954512	MMI NORTH AMERICA, INC.	Jacksonville, FL, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
2022435	Sterigenics U.S., LLC	Tustin, CA, US
2648727	CUSTOMED, INC.	Fajardo, PR, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1055892. Last updated year: 2026. Please use registration number 1055892 when referencing this establishment in official correspondence.