FDA.report

Ambler Surgical

Primary DI
00190660201036
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Pupil dilator ring (PDR) injector
Catalog number
7290T
Device description
Pupil dilator ring (PDR) injector, 5 1/8'', curved shaft, round handle, 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
00190660201036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660201036001906602010361906602010360190660201036

GMDN Terms

TermDefinition
Capsular tension ring inserterA non-sterile hand-operated surgical instrument intended for the implantation of a capsular tension ring (CTR) into the crystalline lens capsular bag during intraocular lens (IOL) surgery (e.g., cataract extraction). It typically consists of a tubular distal tip with internal hooking wire connected to a proximal plunger mechanism, whereby the CTR is hooked and retracted into the tip, the tip inserted into the eye, and the CTR deployed using the plunger. This is a reusable device intended to be sterilized prior to use.

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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