FDA.reportPublic FDA data

NOVO Health Services, LLC

Primary DI
00812564034274
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
124699
Catalog number
124699A
Device description
GreenWrap 54X72 (10 PK) NS
Published
2018-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931875000AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USEAmsco Sterile Recoveries, Inc.1994-06-10FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812564034274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564034274008125640342748125640342740812564034274

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

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
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20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
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00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26
00810194403651AiraAIRA, LLCFRG2026-08-26
00810194403668AiraAIRA, LLCFRG2026-08-26
00810194403675AiraAIRA, LLCFRG2026-08-26
00810194403699AiraAIRA, LLCFRG2026-08-26
00810194403712AiraAIRA, LLCFRG2026-08-26
00810194403729AiraAIRA, LLCFRG2026-08-26
00810194403736AiraAIRA, LLCFRG2026-08-26
08404535030853Brasseler USAPeter Brasseler Holdings, LLCFRG2026-08-21
10724995233386V. MuellerSteris CorporationFRG2026-08-21
00724995241858V. MuellerSteris CorporationFRG2026-08-18
00724995241865V. MuellerSteris CorporationFRG2026-08-18
00724995241872V. MuellerSteris CorporationFRG2026-08-18
00724995241889V. MuellerSteris CorporationFRG2026-08-18
00840118614245Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614252Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614269Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614276Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614283Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614290Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614306Endure IndustriesENDURE INDUSTRIESFRG2026-08-14