FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00810019801754
Brand
NOVO Health Services, LLC
Company
SRI Healthcare, LLC
Model
128012
Catalog number
128012
Device description
Thoracic Pack
Published
2023-03-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810019801754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019801754008100198017548100198017540810019801754

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8138919550customerservice@novohealthservices.com

Regulatory Flags#

DUNS number
117798086
Device count
1
Premarket exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810019802102NOVO Health Services, LLC120507120507F2026-05-15
00810019801709NOVO Health Services, LLC18641864R2022-12-21
00810019802003NOVO Health Services, LLC120507120507F2024-08-15
00810019801846NOVO Health Services, LLC1290471290472023-09-06
00810019802096NOVO Health Services, LLC123350123350D2026-01-12
00810019802041NOVO Health Services, LLC1280151280152024-09-13
00810019801884NOVO Health Services, LLC125083125083B2023-11-02
00810019802089NOVO Health Services, LLC127064127064A2025-05-08
00810019801907NOVO Health Services, LLC125084125084C2024-02-22
00810019801983NOVO Health Services, LLC123443123443A2024-07-31
00810019801839NOVO Health Services, LLC1290301290302023-09-06
00810019801594SRI Healthcare1290771290772021-06-29
00810019802065NOVO Health Services, LLC124010124010B2024-10-07
00810019802072NOVO Health Services, LLC1280161280162024-10-07
00810019802058NOVO Health Services, LLC123320123320B2024-09-13
00810019802010NOVO Health Services, LLC121137121137C2024-09-04
00810019802027NOVO Health Services, LLC123350123350C2024-09-04
00810019802034NOVO Health Services, LLC120750120750D2024-09-04
00810019801976NOVO Health Services, LLC1310171310172024-07-31
00810019801990NOVO Health Services, LLC1207211207212024-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS192900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-19
10809160527177HALYARDAVID MEDICAL, INC.LRO2026-07-17
10809160527313HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527320HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527344HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527351HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527368HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527399HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527405HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527412HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527443HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527450HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527467HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527474HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527481HalyardAVID MEDICAL, INC.LRO2026-07-17
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10198956479845CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956483439CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956488304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956502437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956504868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956507982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956508149CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16