FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00810019801761
Brand
NOVO Health Services, LLC
Company
SRI Healthcare, LLC
Model
1988
Catalog number
1988B
Device description
Drapes, 3/4 Sheet, 2-Pack
Published
2023-03-15
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
KKXDrape, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003755000MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPESMedline Industries, Inc.2001-02-16FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810019801761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019801761008100198017618100198017610810019801761

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, reusableA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8138919550customerservice@novohealthservices.com

Regulatory Flags#

DUNS number
117798086
Device count
1
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
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10812564036022MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036077MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036107MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036183MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036190MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036213MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10812564036381MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20080196017017MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277636726MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660943MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277660950MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
40884389185781MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
20888277635552MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
40888277357038MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
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