FDA.reportPublic FDA data

CYGNUS

Primary DI
10843356102731
Brand
CYGNUS
Company
CYGNUS MEDICAL L.L.C.
Model
TRL1218
Device description
12"x18" 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
10843356102731PackageGS1800In Commercial Distribution
00843356102734PrimaryGS10
30843356102735Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084335610273110843356102731
00843356102734008433561027348433561027340843356102734
3084335610273530843356102735

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 Currently unpublished.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
00198506091278ELMED INCORPORATEDELMED INCORPORATEDLRP2026-06-09
04052536163434neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164585neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164592neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164608neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536177516neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536221202uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221219uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221233uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536162116neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162130neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162147neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162154neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162215neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176724neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176748neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176755neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176762neon3Ulrich GmbH & Co. KGLRP2026-06-08
10198956433755CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956461109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956476950CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956479999CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956485112CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956487475CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490635CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956494817CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956501362CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956505841CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956506381CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08