FDA.reportPublic FDA data

Removable High Level Disinfected (HLD) Label

Primary DI
00843356101645
Brand
Removable High Level Disinfected (HLD) Label
Company
CYGNUS MEDICAL L.L.C.
Model
HLD500
Device description
Removable High Level Disinfected (HLD) Label - 500 Labels per Case
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYVLabel Or Tag, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843356101645PrimaryGS10
30843356101646Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843356101645008433561016458433561016450843356101645
3084335610164630843356101646

GMDN Terms#

Term, Definition table
TermDefinition
Device operating status label/tag, single-useA label or a tag intended to indicate/collect the operating status of a device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed as a locking tag. This is a single-use device.

Regulatory Flags#

DUNS number
103169095
Device count
500
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843356102932CYGNUSLTS12122026-02-16
00843356102949CYGNUSLTS12162026-02-16
00843356102956CYGNUSLTS24242026-02-16
00843356102963CYGNUSASO3E1602026-01-15
00843356102888CYGNUSASO3E1902025-12-16
00843356102895CYGNUSASO6E1602025-12-16
00843356102857CYGNUSCCL5002025-07-11
00843356102864CYGNUSSTR5002025-07-11
00843356101812Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12GIC190R2024-12-31
00843356101829Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12GIC270R2024-12-31
10843356102694CYGNUSGTG-A-20002024-12-11
00843356102741CYGNUSEC03082024-11-20
00843356102758CYGNUSEC0308-SI2024-11-20
00843356102765CYGNUSEC06122024-11-20
00843356102772CYGNUSEC0612-SI2024-11-20
00843356102789CYGNUSEC07132024-11-20
00843356102796CYGNUSEC0713-SI2024-11-20
90843356102744CYGNUSEC03082024-11-20
90843356102751CYGNUSEC0308-SI2024-11-20
90843356102768CYGNUSEC06122024-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540277000011PharmaTagsRMAC Surgical, IncLYV2026-06-09
07540277000004PharmaTagsRMAC Surgical, IncLYV2026-02-06
10198459214035Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-22
10198459204401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459205842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-12-08
10198459189777Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-24
10198459166938Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459181269Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-11-17
10198459159404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-20
10198459148750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-13
10198459141454Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459141546Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-10-06
10198459133381Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459134517Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-29
10198459122712Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122729Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459122736Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-22
10198459115929Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119774Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119781Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459119798Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459120732Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-15
10198459109164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-09-08
10198459074493Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459075056Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10198459078750Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-08-04
10195327655099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10195327668808Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29
10198459024825Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYV2024-07-29