TBR3100NP dispenser with 2 rolls for trial

GUDID 00843356101119

TBR3100NP dispenser with 2 rolls for trial

CYGNUS MEDICAL L.L.C.

Surgical instrument guard, single-use, non-sterile
Primary Device ID00843356101119
NIH Device Record Key2c03f29c-2574-4f0d-b555-c918648867ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameTBR3100NP dispenser with 2 rolls for trial
Version Model NumberTBR200
Company DUNS103169095
Company NameCYGNUS MEDICAL L.L.C.
Device Count1
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
GS100843356101119 [Primary]

FDA Product Code

LRPTray, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-08
Device Publish Date2022-03-31

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 Currently unpublished.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 Currently unpublished.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 Currently unpublished.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 Currently unpublished.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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