FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660111519
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
House suction irrigator
Catalog number
45-337
Device description
House suction irrigator, 5 1/2'', 7.0 x 10.0 French, angled, working length 95mm, thumb plate with cutoff hole
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KARIRRIGATOR, SINUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KARIrrigator, SinusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660111519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660111519001906601115191906601115190190660111519

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660029340Ambler SurgicalThornton triple vertical and 15 degree cutting edg21-328E2021-01-18
00190660000509Ambler SurgicalTendon approximator43-1602021-01-07
00190660002121Ambler SurgicalAir injection cannula1022E2021-01-07
00190660002138Ambler SurgicalAir injection cannula1328E2021-01-07
00190660002145Ambler SurgicalAir injection cannula1023E2021-01-07
00190660002152Ambler SurgicalAir injection cannula1031E2021-01-07
00190660002169Ambler SurgicalAir injection cannula1329E2021-01-07
00190660002176Ambler SurgicalAir injection cannula1026E2021-01-07
00190660002183Ambler SurgicalAir injection cannula1024E2021-01-07
00190660002190Ambler SurgicalAir injection cannula1028E2021-01-07
00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
00190660002213Ambler SurgicalAir injection cannula1027E2021-01-07
00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
00190660002244Ambler SurgicalAir injection cannula1030E2021-01-07
00190660002268Ambler SurgicalAir injection cannula1330E2021-01-07
00190660002329Ambler SurgicalAlio LASIK irrigation cannula5193E2021-01-07
00190660002343Ambler SurgicalAnis cortex aspirating cannula1429E2021-01-07
00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

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Primary DI, Brand, Company table
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06978785665056InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-08-08
00194613022020MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022044MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022051MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022068MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022075MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022082MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00805106849603XTREMEXtreme Personal Care Inc.KAR2025-04-20
00194613022006MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022013MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022037MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022099MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00887482123874Symmetry Surgical®SYMMETRY SURGICAL INC.KAR2024-08-15
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00888515251175BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
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