Ambler Surgical

Primary DI
00190660083205
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
6247E
Catalog number
6247E
Device description
Honan balloon replacement pressure gauge with blue latex free 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
00190660083205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660083205001906600832051906600832050190660083205

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
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00190660100469Ambler SurgicalFiberoptic light cable40-5302021-01-04
00190660100476Ambler SurgicalFiberoptic light cable40-5352021-01-04
00190660100483Ambler SurgicalFiberoptic light cable40-8402021-01-04
00190660100490Ambler SurgicalFiberoptic light cable40-8502021-01-04
00190660100506Ambler SurgicalFiberoptic light cable40-8602021-01-04
00190660100513Ambler SurgicalFiberoptic light cable40-5402021-01-04
00190660100520Ambler SurgicalFiberoptic light cable40-6002021-01-04
00190660100537Ambler SurgicalFiberoptic light cable40-6102021-01-04
00190660100544Ambler SurgicalFiberoptic light cable40-1002021-01-04
00190660100551Ambler SurgicalFiberoptic light cable40-6202021-01-04

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Primary DI, Brand, Company table
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M6332904600JEDMEDJEDMED INSTRUMENT COMPANYLCC2022-12-19
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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
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