FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00810019801730
Brand
NOVO Health Services, LLC
Company
SRI Healthcare, LLC
Model
128011
Catalog number
128011
Device description
Baby Pack, NICU
Published
2023-01-20
Public version status
New
Distribution status
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
00810019801730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019801730008100198017308100198017300810019801730

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.

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
00810019801754NOVO Health Services, LLC1280121280122023-03-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233017276Busse Hospital DisposablesROBERT BUSSE & CO., INC.LRO2026-05-28
10809160522059HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522073HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522080HalyardAVID MEDICAL, INC.LRO2026-05-28
10885632522079SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-05-28
10653160393702MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-05-27
10653160393757CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-05-27
10809160521878HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521885HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521892HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521922HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521939HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521946HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521953HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521960HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521977HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521991HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522004HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522011HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522028HalyardAVID MEDICAL, INC.LRO2026-05-27
H65857028265Henry ScheinHENRY SCHEIN, INC.LRO2022-01-28
H65857028255Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028285Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028925Henry ScheinHENRY SCHEIN, INC.LRO2022-01-26
H65857028915Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028905Henry ScheinHENRY SCHEIN, INC.LRO2022-01-18
H65857028875Henry ScheinHENRY SCHEIN, INC.LRO2021-12-29
H65857028865Henry ScheinHENRY SCHEIN, INC.LRO2021-12-21
H65857028855Henry ScheinHENRY SCHEIN, INC.LRO2021-12-14
H65857028845Henry ScheinHENRY SCHEIN, INC.LRO2021-12-13