Honan Intraocular Pressure Reducer

GUDID 00851607007233

GAUGE (LATEX FREE), CASE, SILICONE TUBING + RELIEF VALVE WITH 1 BOX (12) DISPOSABLE BELLOWS & HEADBANDS

LEBANON CORP, THE

Intraocular pressure-reducing system
Primary Device ID00851607007233
NIH Device Record Key4f2ce245-556c-49fd-a0e3-c3fb55b0fa89
Commercial Distribution StatusIn Commercial Distribution
Brand NameHonan Intraocular Pressure Reducer
Version Model Number3005
Company DUNS093218832
Company NameLEBANON CORP, THE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851607007233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCCApplicator, Ocular Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-23

On-Brand Devices [Honan Intraocular Pressure Reducer]

00851607007257LUER ADAPTER
00851607007240SILICONE TUBING
00851607007233GAUGE (LATEX FREE), CASE, SILICONE TUBING + RELIEF VALVE WITH 1 BOX (12) DISPOSABLE BELLOWS & HE
00851607007226GAUGE (LATEX FREE), CASE, SILICONE TUBING WITH 1 BOX (12) DISPOSABLE BELLOWS & HEADBANDS
008516070072191 BOX (12) SINGLE USE DISPOSABLE BELLOWS & HEADBANDS
00851607007202CASE, BLACK W/ ZIPPER
00851607007196BLACK BULB W/ FILTER & RING (NEW STYLE)
00851607007189BLUE BULB - AIR PUMP (LATEX FREE)
00851607007172BLACK BULB - AIR PUMP(LATEX)
00851607007165SCREWS FOR PALM REST (EACH)
00851607007158CHECK VALVE (ONE PIECE DESIGN)
00851607007141CHECK VALVE FILTER (OLD STYLE)
00851607007134CHECK VALVE (NEW STYLE)
00851607007127FERRULE
00851607007110FERRULE & LUER CONNECTOR
00851607007103CRYSTAL (PLASTIC GAUGE COVER)
00851607007097KNURLED KNOB
00851607007080PRESSURE GAUGE & BLUE BULB AIR PUMP (LATEX FREE)
00851607007073PRESSURE GAUGE & BLACK BULB AIR PUMP (LATEX)
00851607007066RELIEF VALVE
00851607007059TUBING
00851607007042DIVIDED HEADBAND
00851607007035SINGLE HEADBAND
00851607007028BELLOWS (REUSABLE)
00851607007011GAUGE, CASE, TUBING, WITH REUSABLE BELLOWS & HEADBAND + RELIEF VALVE
00851607007004GAUGE, CASE, TUBING, WITH REUSABLE BELLOWS & HEADBAND

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