FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660083151
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
6250E
Catalog number
6250E
Device description
Honan balloon replacement black latex bulb
Published
2016-09-29
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
00190660083151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660083151001906600831511906600831510190660083151

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
DM exempt
true
Lot or batch
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660083373Ambler SurgicalAmbler ingrown tissue hook37-1292021-01-07
00190660086343Ambler SurgicalR-Style nerve hook37-8252021-01-07
00190660086350Ambler SurgicalR-Style nerve hook37-8272021-01-07
00190660086367Ambler SurgicalR-Style nerve hook37-8262021-01-07
00190660086374Ambler SurgicalR-Style nerve hook37-8282021-01-07
00190660086381Ambler SurgicalYasargil micro hook37-8722021-01-07
00190660086398Ambler SurgicalYasargil micro hook37-8702021-01-07
00190660121549Ambler SurgicalR-Style needle57-4262021-01-07
00190660121556Ambler SurgicalR-Style needle57-4282021-01-07
00190660141578Ambler SurgicalSalinger reduction instrument73-1252021-01-07
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04

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
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
10851607007216Honan Intraocular Pressure ReducerLEBANON CORP, THELCC2016-08-23