Home GUDID 00190660103514 Ambler Surgical
Primary DI 00190660103514
Brand Ambler Surgical
Company AMBLER SURGICAL CORP.
Model Bores optic zone marker
Catalog number 8842E
Device description Bores optic zone marker, 3 3/4'', 11.0mm diameter, 3.0mm ring height, round handle
Published 2021-01-04
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HMR Marker, ocular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HMR Marker, Ocular Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190660103514 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190660103514 00190660103514 190660103514 0190660103514
GMDN Terms# Term, Definition table Term Definition Scleral marker, reusable A 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 table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 015272206 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00190660100360 Ambler Surgical Fiberoptic light cable 40-800 2021-01-04 00190660100377 Ambler Surgical Fiberoptic light cable 40-500 2021-01-04 00190660100384 Ambler Surgical Fiberoptic light cable 40-810 2021-01-04 00190660100391 Ambler Surgical Fiberoptic light cable 40-505 2021-01-04 00190660100407 Ambler Surgical Fiberoptic light cable 40-820 2021-01-04 00190660100414 Ambler Surgical Fiberoptic light cable 40-830 2021-01-04 00190660100421 Ambler Surgical Fiberoptic light cable 40-510 2021-01-04 00190660100438 Ambler Surgical Fiberoptic light cable 40-515 2021-01-04 00190660100445 Ambler Surgical Fiberoptic light cable 40-520 2021-01-04 00190660100452 Ambler Surgical Fiberoptic light cable 40-525 2021-01-04 00190660100469 Ambler Surgical Fiberoptic light cable 40-530 2021-01-04 00190660100476 Ambler Surgical Fiberoptic light cable 40-535 2021-01-04 00190660100483 Ambler Surgical Fiberoptic light cable 40-840 2021-01-04 00190660100490 Ambler Surgical Fiberoptic light cable 40-850 2021-01-04 00190660100506 Ambler Surgical Fiberoptic light cable 40-860 2021-01-04 00190660100513 Ambler Surgical Fiberoptic light cable 40-540 2021-01-04 00190660100520 Ambler Surgical Fiberoptic light cable 40-600 2021-01-04 00190660100537 Ambler Surgical Fiberoptic light cable 40-610 2021-01-04 00190660100544 Ambler Surgical Fiberoptic light cable 40-100 2021-01-04 00190660100551 Ambler Surgical Fiberoptic light cable 40-620 2021-01-04
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published G346BP01RSS0 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HMR 2026-03-02 G346ET160 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HMR 2026-02-17 00642356004709 Mastel Surgical Inc. Mastel Surgical Inc. HMR 2026-02-11 B382S34556140 Surgical Direct Surgical Direct, Inc. HMR 2026-02-04 B382S4901000 Surgical Direct Surgical Direct, Inc. HMR 2026-02-04 B382S5616020 Surgical Direct Surgical Direct, Inc. HMR 2026-02-04 G346ET390 Epsilon USA EPSILON EYE CARE PRIVATE LIMITED HMR 2026-01-21 B382S345201000 Surgical Direct Surgical Direct, Inc. HMR 2025-12-10 B382SD9345561010 Surgical Direct Surgical Direct, Inc. HMR 2025-09-18 B382SD934557100 Surgical Direct Surgical Direct, Inc. HMR 2025-09-18 00757770492312 Bausch + Lomb Bausch & Lomb Incorporated HMR 2025-08-04 00194613001964 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613002688 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613040093 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613042431 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613049249 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613049539 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613049706 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613049775 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613049782 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613049799 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613049805 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613056834 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613086978 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613086985 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613102463 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613102524 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613102531 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613102647 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01 00194613106256 MSI Precision Specialty Instruments Med Saver, Inc. HMR 2025-08-01
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