SingleCycle Biohazard Self-Sealing label 20"

GUDID 30843356100649

SingleCycle Biohazard Self-Sealing label 20" 500 per case

CYGNUS MEDICAL L.L.C.

Device operating status label/tag, single-use
Primary Device ID30843356100649
NIH Device Record Key2a891615-4a39-4125-be27-235129b47b8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingleCycle Biohazard Self-Sealing label 20"
Version Model NumberSCB20
Company DUNS103169095
Company NameCYGNUS MEDICAL L.L.C.
Device Count500
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100843356100648 [Primary]
GS130843356100649 [Unit of Use]

FDA Product Code

PXVGeneral Purpose Instrument Tray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-08
Device Publish Date2023-11-30

Devices Manufactured by CYGNUS MEDICAL L.L.C.

00843356101812 - Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 122025-01-08 Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R Version on Gator Clips - All cli
00843356101829 - Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 122025-01-08 Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R version on Gator Clips - All cli
10843356102694 - CYGNUS2024-12-19 Tip Gard 500 Per Bag, 2000 Per Case
90843356102744 - CYGNUS2024-11-28 Enhanced Coating Single Cycle, EC0308 100 per case
90843356102751 - CYGNUS2024-11-28 Enhanced Coating Single Cycle, EC0308 with label 100 per case
90843356102768 - CYGNUS2024-11-28 Enhanced Coating Single Cycle, EC0612 100 per case
90843356102775 - CYGNUS2024-11-28 Enhanced Coating Single Cycle, EC0612 with label 100 per case
90843356102782 - CYGNUS2024-11-28 Enhanced Coating Single Cycle, EC0713 60 per case

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