FDA.reportPublic FDA data

CYGNUS

Primary DI
10843356102694
Brand
CYGNUS
Company
CYGNUS MEDICAL L.L.C.
Model
GTG-A-2000
Device description
Tip Gard 500 Per Bag, 2000 Per Case
Published
2024-12-11
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
LXZGuard, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXZGuard, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843356102694PrimaryGS10
90843356102690Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084335610269410843356102694
9084335610269090843356102690

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103169095
Device count
2000
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 Currently unpublished.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 Currently unpublished.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
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
90843356102775CYGNUSEC0612-SI2024-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770418640Bausch + LombBausch & Lomb IncorporatedLXZ2025-08-18
04262488440044TissueGUARDTissueGUARD GmbHLXZ2025-04-25
04262488440037TissueGUARDTissueGUARD GmbHLXZ2025-04-25
04262488440020TissueGUARDTissueGUARD GmbHLXZ2025-04-24
04262488440013TissueGUARDTissueGUARD GmbHLXZ2025-04-24
00822409101160N/AOrtho Development CorporationLXZ2023-10-06
B7689188290Buxton BioMedicalBuxton Biomedical IncLXZ2023-07-07
00822409104031n/aOrtho Development CorporationLXZ2022-05-01
00847399007186MicroAire® Microaire Surgical Instruments LLCLXZ2022-03-30
00847399000798MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399000804MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399003690MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399007001MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-29
107073877920053M™ Attest™3M COMPANYLXZ2021-06-18
107073877920123M™ Attest™3M COMPANYLXZ2021-06-18
107073877920293M™ Attest™3M COMPANYLXZ2021-06-18
307073874694443M™ Comply™3M COMPANYLXZ2021-06-18
307073874694513M™ Comply™3M COMPANYLXZ2021-06-18
307073874694683M™ Comply™3M COMPANYLXZ2021-06-18
507073877920033M™ Attest™3M COMPANYLXZ2021-06-18
507073877920103M™ Attest™3M COMPANYLXZ2021-06-18
507073877920273M™ Attest™3M COMPANYLXZ2021-06-18
507073874694483M™ Comply™3M COMPANYLXZ2021-06-18
507073874694553M™ Comply™3M COMPANYLXZ2021-06-18
507073874694623M™ Comply™3M COMPANYLXZ2021-06-18
10884527010219DevonCardinal Health, Inc.LXZ2018-06-23