FDA.reportPublic FDA data

CYGNUS

Primary DI
10843356102717
Brand
CYGNUS
Company
CYGNUS MEDICAL L.L.C.
Model
TRL1212
Device description
12"x12" Tray Liner 50 parts per bag
Published
2024-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843356102717PackageGS11200In Commercial Distribution
00843356102710PrimaryGS10
30843356102711Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084335610271710843356102717
00843356102710008433561027108433561027100843356102710
3084335610271130843356102711

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray cover, single-useA flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103169095
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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 Currently unpublished.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
10198956555839CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-26
10198956611894CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-26
10198956623248CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-26
10198956628731CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-26
10198956629929CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-26
10198956592568CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956593886CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956603592CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956611856CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956612815CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956612921CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956619203CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956620957CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956623286CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956623507CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
B098AMS197690Aligned Medical SolutionsAligned Medical SolutionsLRP2026-10-23
03661219327929LANDANGERLANDANGERLRP2026-10-22
10198956558793CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956572447CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956578470CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956589575CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956599901CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956604216CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611450CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611863CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956617384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956619241CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
00810161900992EARP, IMPLANT CADDY 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901005EARP, IMPLANT LID 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901012EARP, IMPLANT CADDY 14X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16