Home GUDID 00190660218416 Ambler Surgical
Primary DI 00190660218416
Brand Ambler Surgical
Company AMBLER SURGICAL CORP.
Model Scleral eye shield
Catalog number 9302E
Device description Scleral eye shield, large, 22.0mm x 30.0mm, non-reflective exterior surface, sold as a pair
Published 2021-01-04
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HOY Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190660218416 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 00190660218416 00190660218416 190660218416 0190660218416
GMDN Terms# Term, Definition table Term Definition Surgical eye pressure shield A non-sterile device intended to cover and mechanically protect the eyes of a patient during surgery to prevent potential ocular pressure hazards/injury associated with surgery (e.g., resulting from inadvertent pressure being applied to the eye by healthcare professionals, equipment, or due to the orientation of the patient). It is designed as a rigid external eye shield (e.g., goggle like) intended to adhere to the face. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 015272206 Device count 1 DM exempt true Premarket exempt true Lot or batch true Manufacturing date on label true No natural rubber latex 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 00757770535583 Bausch + Lomb Bausch & Lomb Incorporated HOY 2026-04-30 16931918105420 Alleset GRI Medical & Electronic Technology Co., Ltd. HOY 2026-04-10 10620974004285 BetterShield Southmedic Incorporated HOY 2025-12-19 D2481009320 """Heidi"" Protective Eyewear " HAGER WORLDWIDE, INC. HOY 2025-10-22 D2481009330 """Ella"" Protective Eyewear " HAGER WORLDWIDE, INC. HOY 2025-10-22 D2481009350 """Lucy"" Protective Eyewear " HAGER WORLDWIDE, INC. HOY 2025-10-22 10827989003504 Health Care Logistics, Inc® Health Care Logistics, Inc. HOY 2025-01-08 TQ26126151971 Top Quality Manufacturing TOP QUALITY MANUFACTURING, INC. HOY 2024-12-09 10889483047910 SunMed LLC SUNMED, LLC HOY 2024-11-11 10887482176815 Bovie ASPEN SURGICAL PRODUCTS, INC. HOY 2024-08-26 00194613017101 MSI Precision Specialty Instruments Med Saver, Inc. HOY 2024-08-15 00194613028190 MSI Precision Specialty Instruments Med Saver, Inc. HOY 2024-08-15 00194613002770 MSI Precision Specialty Instruments Med Saver, Inc. HOY 2024-04-25 00630094055114 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094055138 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094055145 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094055190 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094404721 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094540160 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094540337 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094540474 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094551913 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094551937 Bioseal Inc. BIOSEAL HOY 2024-01-29 00630094053707 Bioseal Inc. BIOSEAL HOY 2024-01-26 00630094053738 Bioseal Inc. BIOSEAL HOY 2024-01-26 00630094053905 Bioseal Inc. BIOSEAL HOY 2024-01-26 00630094540016 Bioseal Inc. BIOSEAL HOY 2024-01-26 08052276029638 Eye Shield AKTIVE SRL HOY 2024-01-15 00630094183411 Bioseal Inc. BIOSEAL HOY 2023-10-05 00630094183459 Bioseal Inc. BIOSEAL HOY 2023-10-05
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