FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00812564032119
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
121312
Catalog number
121312B
Device description
PLR BASIC PACK
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
00812564032119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564032119008125640321198125640321190812564032119

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
Height11Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8138919551customerservice@novohealthservices.com

Regulatory Flags#

DUNS number
069936106
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810019801433NOVO Health Services, LLC126070126070A2021-03-30
00810019801440NOVO Health Services, LLC860486042021-03-30
00810019801488NOVO Health Services, LLC860386032021-03-30
00810019801426NOVO Health Services, LLC1290761290762021-01-25
00810019801457NOVO Health Services, LLC129076129076A2021-01-25
00810019801464NOVO Health Services, LLCB-097-2B-097-22021-01-25
00810019801471NOVO Health Services, LLC121232121232D2021-01-25
00810019801358NOVO Health Services, LLC14000140002021-01-11
00810019801365NOVO Health Services, LLC14001140012021-01-11
00810019801372NOVO Health Services, LLC14002140022021-01-11
00810019801389NOVO Health Services, LLC14003140032021-01-11
00810019801396NOVO Health Services, LLC14004140042021-01-11
00810019801402NOVO Health Services, LLC14005140052021-01-11
00810019801419NOVO Health Services, LLC14006140062021-01-11
00810019800412NOVO Health Services, LLC1290531290532020-07-30
00810019800429NOVO Health Services, LLC1290541290542020-07-30
00810019800443NOVO Health Services, LLC1290561290562020-07-30
00810019800917NOVO Health Services, LLC123341123341B2020-07-30
00810019801150NOVO Health Services, LLC1290571290572020-07-30
00810019801167NOVO Health Services, LLC1290581290582020-07-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521830HalyardAVID MEDICAL, INC.LRO2026-05-26
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10198956413757CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
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10198956457096CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457713CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956457959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956460638CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956461741CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956462014CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956463516CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956464360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465831CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956465855CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25