FDA.reportPublic FDA data

CYGNUS

Primary DI
00843356102802
Brand
CYGNUS
Company
CYGNUS MEDICAL L.L.C.
Model
TBLT-RL
Device description
Eight 100' rolls of Tray Belt Low Temperature
Published
2024-09-11
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
LRPTray, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843356102802PrimaryGS10
90843356102805Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843356102802008433561028028433561028020843356102802
9084335610280590843356102805

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-useA device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.

Regulatory Flags#

DUNS number
103169095
Device count
8
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 Currently unpublished.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 Currently unpublished.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
10198956309012CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956404243CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956437159CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956489134CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956495579CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956495616CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956501607CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956501850CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-03
10198956397057CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956408722CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956441798CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956446366CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956471351CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956485761CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956492684CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956493513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956495425CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956498983CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
10198956500389CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-01
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
G586961003A0Novo SurgicalNOVO SURGICAL, INC.LRP2024-02-22
G429MSS820160Stainless steel bowl small 6CMMEED SKILL SURGICALLRP2023-03-03
G141588222990Carnegie Surgical LLCCarnegie Surgical LLCLRP2023-02-13
07899798205796QuinelatoSchobell Industrial LtdaLRP2022-12-20
10080196055159MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196818778MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196848041MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196996681MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10190001934897MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190021MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01