FDA.report

Ambler Surgical

Primary DI
00190660103415
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Bores low-profile optic zone marker
Catalog number
8934E
Device description
Bores low-profile optic zone marker, 3 3/4'', 9.0mm diameter, 1.65mm ring height, round handle
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

Product Codes

CodeName
HMRMarker, ocular

Product Code Classifications

CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660103415PrimaryGS10

GMDN Terms

TermDefinition
Scleral marker, reusableA manual instrument intended to be used to indent or imprint the surface of the sclera during an ophthalmic surgical or perioperative procedure. It is typically a hand-held instrument or a thimble-like device (placed on the end of a finger) and is made of metal (e.g., high-grade stainless steel). Various types are available, including the Gass scleral marker that creates a minuscule indentation, the Awh scleral marker that creates parallel scored lines, and the Awh horseshoe design. The device is typically used for retinal detachment surgery. 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

Other Devices From This Company

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.HMR2025-09-18
00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04
00194613001964MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613002688MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613040093MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613042431MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049249MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049539MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049706MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049775MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049782MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049799MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049805MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613056834MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613086978MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613086985MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102463MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102524MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102531MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102647MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613106256MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01