FDA.reportPublic FDA data

HONAN BALLOON WITH PRESS VALVE

Primary DI
00841668112137
Brand
HONAN BALLOON WITH PRESS VALVE
Company
KATENA PRODUCTS, INC.
Model
K 9-8410
Catalog number
K 9-8410
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
00841668112137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668112137008416681121378416681121370841668112137

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
DM exempt
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841668144367KatenaK3-9266K3-92662026-03-31
00841668144374KatenaK3-9267K3-92672026-03-31
00841668144381KatenaK5-6220K5-62202026-03-31
00841668144398KatenaK3-9268K3-92682026-03-31
00841668144404KatenaK3-9269K3-92692026-03-31
00841668144428KatenaK3-9270K3-92702026-03-31
00841668144435KatenaK3-9274K3-92742026-03-31
00841668144442KatenaK3-9271K3-92712026-03-31
00841668144497BLINK60-127560-12752026-03-26
00841668144619BLINK60-163760-16372026-03-26
00841668144626BLINK60-163860-16382026-03-26
00841668144657BLINK60-500160-50012026-03-26
00841668144855BLINK60-510860-51082026-03-26

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
00841668112144HEADBAND FOR HONAN BALLOONKATENA PRODUCTS, INC.LCC2016-09-22
00841668112151HONAN BALLOON HEADBAND (NO LATEX)KATENA PRODUCTS, INC.LCC2016-09-22
10851607007216Honan Intraocular Pressure ReducerLEBANON CORP, THELCC2016-08-23