FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00812564032669
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
122114
Catalog number
122114C
Device description
OPEN HEART SET UP PACK
Published
2018-09-24
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
00812564032669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564032669008125640326698125640326690812564032669

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA general-purpose collection of various sterile surgical instruments, dressings, and materials intended to be used to assist a range of surgical procedures across multiple clinical specialities. It does not contain pharmaceuticals. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Inch
Weight12.4Pound
Width16Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8138919550customerservice@novohealthservices.com

Regulatory Flags#

DUNS number
069936106
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810019800627NOVO Health Services, LLC1262681262682020-03-10
00812564030528NOVO Health Services, LLC120307120307B2018-09-24
00812564030634NOVO Health Services, LLC120424120424B2018-09-24
00812564030894NOVO Health Services, LLC120621120621D2018-09-24
00812564031914NOVO Health Services, LLC121168121168B2018-09-24
00812564032102NOVO Health Services, LLC121311121311G2018-09-24
00812564032300NOVO Health Services, LLC121705121705E2018-09-24
00812564033635NOVO Health Services, LLC124175124175B2018-09-24
00812564033741NOVO Health Services, LLC124255124255B2018-09-24
00812564033949NOVO Health Services, LLC124512124512C2018-09-24
00812564033956NOVO Health Services, LLC124513124513C2018-09-24
00812564033963NOVO Health Services, LLC124514124514C2018-09-24
00812564033970NOVO Health Services, LLC124515124515C2018-09-24
00812564033987NOVO Health Services, LLC124516124516F2018-09-24
00812564034380NOVO Health Services, LLC124922124922D2018-09-24
00812564034625NOVO Health Services, LLC1260611260612018-09-24
00812564034830NOVO Health Services, LLC126267126267B2018-09-24
00812564034977NOVO Health Services, LLC63206320D2018-10-01
00812564035066NOVO Health Services, LLC1273361273362018-09-24
00812564035103NOVO Health Services, LLC1273641273642018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527726HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527733HalyardAVID MEDICAL, INC.LRO2026-07-22
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B098AMS187270Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
10653160394068CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-21
10653160394105MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394150MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394167MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394174MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394266MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394280MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10809160527597HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527627HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527641HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527689HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527696HalyardAVID MEDICAL, INC.LRO2026-07-21
B098AMS15342A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
B098AMS191710Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
B098AMS192910Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
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10198956333895CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956352261CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956361751CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956372801CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956373938CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956382176CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956387614CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956393677CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20