FDA.reportPublic FDA data

Bundle - SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED IN

Primary DI
30843356101691
Brand
Bundle - SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED IN
Company
CYGNUS MEDICAL L.L.C.
Model
IT0612-SI
Device description
Bundle - IT0612, SingleCycle Disposable Instrument Tray and "BIOHAZARD/SOILED INSTRUMENTS" tamper-proof label with adhesive backing - 100 Trays & 100 Labels
Published
2020-09-24
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
PXVGeneral Purpose Instrument Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXVGeneral Purpose Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843356101690PrimaryGS10
30843356101691Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843356101690008433561016908433561016900843356101690
3084335610169130843356101691

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, single-use, non-sterileA non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury. It is available in various forms (e.g., rack, rest, puncture cushion, pocket, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103169095
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
90843356102744CYGNUSEC03082024-11-20
90843356102751CYGNUSEC0308-SI2024-11-20
90843356102768CYGNUSEC06122024-11-20
90843356102775CYGNUSEC0612-SI2024-11-20
90843356102782CYGNUSEC07132024-11-20
90843356102799CYGNUSEC0713-SI2024-11-20
00843356102840CYGNUSHLD250R2024-11-20
90843356102805CYGNUSTBLT-RL2024-09-11
00843356102819CYGNUSSCC152024-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956281668CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
50198956244588CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
50198956137477CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
50198956057508CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
90843356102744CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102751CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102768CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102775CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102782CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102799CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
50197106773282CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
00843356102819CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102826CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102833CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00811687031962MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032440MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032457MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032464MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032471MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032815MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00840183500016BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183515256BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183515270BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183518127BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183518158BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183518165BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183505400BR Surgical, LLCBR Surgical, LLCPXV2024-07-19
00840183504977BR Surgical, LLCBR Surgical, LLCPXV2024-07-18
50197106620128CARDINAL HEALTHCardinal Health 200, LLCPXV2024-05-16
50197106527373CARDINAL HEALTHCardinal Health 200, LLCPXV2024-02-08