FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00812564031334
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
120856
Catalog number
120856E
Device description
C-Section Pack
Published
2018-09-24
Public version status
Update
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
00812564031334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564031334008125640313348125640313340812564031334

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
Height9Inch
Weight9.4Pound
Width15Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8138919550customerservice@novohealthservices.com

Regulatory Flags#

DUNS number
069936106
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Serial number
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
10653160393702MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-05-27
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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
H65857028935Henry ScheinHENRY SCHEIN, INC.LRO2022-01-25
H65857028945Henry ScheinHENRY SCHEIN, INC.LRO2022-01-25
H65857028915Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028965Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028975Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028985Henry 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