FDA.report

Ambler Surgical

Primary DI
00190660089641
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Ambler III cartridge injector
Catalog number
7284T
Device description
Ambler III cartridge injector, 5 3/4'', front loading cartridge, for use with Alcon® Type D cartridges, plunger mechanism, titanium
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

Related Records

Contact Domains

Product Codes

CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications

CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660089641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660089641001906600896411906600896410190660089641

GMDN Terms

TermDefinition
Manual intraocular lens injector, reusableA hand-held, manual, ophthalmic surgical instrument designed to expel (launch) a prepared folded intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic surgery. Commonly known as the handpiece, this device is used to carefully exert pressure on the prepared IOL to push it out of the IOL insertion cartridge. It is typically made of lightweight metal materials [e.g., titanium (Ti)], has a central plunger that is activated by a precise mechanism (e.g., a screw thread), and has a mechanism at the distal end to hold/grip the insertion cartridge. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
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00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

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