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 Currently unpublished.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
00198506093746ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-22
00642356005645SteriBestMastel Surgical Inc.LRP2026-07-22
00840311264032Cortera Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-07-20
10198956493353CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956501836CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956514683CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956516762CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956518896CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956519589CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956528093CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956529182CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532502CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532779CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532786CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956533516CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956533752CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956535091CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956493612CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956501973CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956526181CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956530935CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956531925CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
03661219527046DELACROIX-CHEVALIERLANDANGERLRP2026-07-12
10198956392977CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956449992CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956482401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956499195CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956505513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956507180CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518438CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09