FDA.reportPublic FDA data

HONAN BALLOON HEADBAND (NO LATEX)

Primary DI
00841668112151
Brand
HONAN BALLOON HEADBAND (NO LATEX)
Company
KATENA PRODUCTS, INC.
Model
K 9-8412
Catalog number
K 9-8412
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00841668112151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668112151008416681121518416681121510841668112151

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

Contacts#

Phone, Email table
PhoneEmail
(973) 989-1600globe@katena.com

Regulatory Flags#

DUNS number
085668598
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668146460BarronK20-2165K20-21652026-06-10
00841668146484BarronK20-2167K20-21672026-06-10
00841668146491BarronK20-2170K20-21702026-06-10
00841668146507BarronK20-2172K20-21722026-06-10
00841668146514BarronK20-2175K20-21752026-06-10
00841668146521BarronK20-2177K20-21772026-06-10
00841668146538BarronK20-2180K20-21802026-06-10
00841668146545BarronK20-2182K20-21822026-06-10
00841668146552BarronK20-2185K20-21852026-06-10
00841668146569BarronK20-2187K20-21872026-06-10
00841668146576BarronK20-2195K20-21952026-06-10
00841668146590BarronK20-2190K20-21902026-06-10
00841668146606BarronK20-2192K20-21922026-06-10
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31

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
00190660083090Ambler SurgicalAMBLER SURGICAL CORP.LCC2016-09-29
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
10851607007216Honan Intraocular Pressure ReducerLEBANON CORP, THELCC2016-08-23