FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00812564037558
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
5209
Catalog number
5209D
Device description
SM MAYO TRAY
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
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812564037558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564037558008125640375588125640375580812564037558

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical drape, reusable, sterileA sterile protective covering made of natural or synthetic materials, or both, designed to isolate a site of surgical incision or a surgical field from contamination (e.g., microbial, substance) in various clinical settings (e.g., in an operating room or catheterization laboratory). The device may also be used to protect a patient from heat/flame during a surgical procedure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1.5Inch
Weight3.2Pound
Width13Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8138919550customerservice@novohealthservices.com

Regulatory Flags#

DUNS number
069936106
Device count
1
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
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498673Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498772Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196025893MEDLINEMEDLINE INDUSTRIES, INC.KKX2022-10-03
10080196496563Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
10080196496662Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
10080196497713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
10080196007134MedlineMEDLINE INDUSTRIES, INC.KKX2021-09-22
10080196311033MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196325825MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196333950MedlineMEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196571932MedlineMEDLINE INDUSTRIES, INC.KKX2021-01-26
10080196744213MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-11
10080196748150MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-10
10080196747115MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-09