FDA.reportPublic FDA data

Honan Intraocular Pressure Reducer

Primary DI
00851607007080
Brand
Honan Intraocular Pressure Reducer
Company
LEBANON CORP, THE
Model
505
Device description
PRESSURE GAUGE & BLUE BULB AIR PUMP (LATEX FREE)
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LCCApplicator, Ocular Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCCApplicator, Ocular PressureOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K820526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K820526000RELIEF VALVE-HONAN INTRAOC. PRESSUREThe Lebanon Corp.1982-03-25LCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851607007080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851607007080008516070070808516070070800851607007080

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular pressure-reducing systemAn assembly of manually-operated devices designed to reduce the intraocular pressure (IOP), i.e., internal pressure of the eye fluids, by applying a controlled, external, mechanical compression to the surface of the eye in preparation for ophthalmic surgery. It typically consists of a headband with an attached inflatable bellows that applies pressure, an air pump (e.g., a squeeze bulb), a pressure indicator (e.g., a manometer), and tubing. It is typically used prior to surgery to induce a temporary reduction of the IOP creating a condition known as "soft surgical eye", which helps in the prevention of haemorrhaging thus reducing the risk of a surgical procedure. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093218832
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851607007216Honan Intraocular Pressure Reducer7032016-08-23
00851607007004Honan Intraocular Pressure Reducer20502016-08-19
00851607007011Honan Intraocular Pressure Reducer20552016-08-23
00851607007028Honan Intraocular Pressure Reducer1502016-08-23
00851607007035Honan Intraocular Pressure Reducer2002016-08-23
00851607007042Honan Intraocular Pressure Reducer2102016-08-23
00851607007059Honan Intraocular Pressure Reducer3002016-08-23
00851607007066Honan Intraocular Pressure Reducer4002016-08-23
00851607007073Honan Intraocular Pressure Reducer5002016-08-23
00851607007097Honan Intraocular Pressure Reducer5102016-08-23
00851607007103Honan Intraocular Pressure Reducer5152016-08-23
00851607007110Honan Intraocular Pressure Reducer5202016-08-23
00851607007127Honan Intraocular Pressure Reducer5252016-08-23
00851607007134Honan Intraocular Pressure Reducer5302016-08-23
00851607007141Honan Intraocular Pressure Reducer5352016-08-23
00851607007158Honan Intraocular Pressure Reducer5412016-08-23
00851607007165Honan Intraocular Pressure Reducer5432016-08-23
00851607007172Honan Intraocular Pressure Reducer5502016-08-23
00851607007189Honan Intraocular Pressure Reducer5552016-08-23
00851607007196Honan Intraocular Pressure Reducer5602016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6332904600JEDMEDJEDMED INSTRUMENT COMPANYLCC2022-12-19
20813172025207Dental Grip ® Powder-FreeINNOVATIVE HEALTHCARE CORPORATIONLCC2022-12-08
20813172025214Dental Grip ® Powder-FreeINNOVATIVE HEALTHCARE CORPORATIONLCC2022-12-08
20813172025221Dental Grip ® Powder-FreeINNOVATIVE HEALTHCARE CORPORATIONLCC2022-12-08
20813172025238Dental Grip ® Powder-FreeINNOVATIVE HEALTHCARE CORPORATIONLCC2022-12-08
20813172025245Dental Grip ® Powder-FreeINNOVATIVE HEALTHCARE CORPORATIONLCC2022-12-08
00851607007240Honan Intraocular Pressure ReducerLEBANON CORP, THELCC2016-10-17
00851607007257Honan Intraocular Pressure ReducerLEBANON CORP, THELCC2016-10-17
00190660083076Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083083Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
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00190660083106Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083113Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083120Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083137Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083144Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083151Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083168Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083175Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083182Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083199Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083205Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083212Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083229Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083236Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083243Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00190660083250Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
00841668112137HONAN BALLOON WITH PRESS VALVEKATENA PRODUCTS, INC.LCC2016-09-22
00841668112144HEADBAND FOR HONAN BALLOONKATENA PRODUCTS, INC.LCC2016-09-22
00841668112151HONAN BALLOON HEADBAND (NO LATEX)KATENA PRODUCTS, INC.LCC2016-09-22