FDA.reportPublic FDA data

Braunstein Marker

Primary DI
05060480407992
Brand
Braunstein Marker
Company
BLINK MEDICAL LIMITED
Model
90-1017
Published
2023-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HMQMarker, Sclera

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMQMarker, ScleraOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060480402492PackageGS110In Commercial Distribution
05060480407992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060480402492050604804024925060480402492
05060480407992050604804079925060480407992

GMDN Terms#

Term, Definition table
TermDefinition
Scleral marker, single-useA 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) or synthetic polymer materials. 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 single-use device.

Regulatory Flags#

DUNS number
738288096
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056785303657CANNULA KIT 1 - KAISER PERMANENTE MARTINEZ67-0009A2026-05-12
05056785303633Cataract Inst Set - Spokane Anderson67-0028A2026-05-06
05056785302971Kratz Plastic Mechanical Speculum31-30052026-02-04
05056785302995Plastic Solid Bladed Mechanical Speculum31-30062026-02-04
05056785303350Double Ended Y and ICL Shaped Manipulator41-90152026-02-04
05056785302988Kratz Plastic Mechanical Speculum31-30052026-02-04
05056785303008Plastic Solid Bladed Mechanical Speculum31-30062026-02-04
05056785303367Double Ended Y and ICL Shaped Manipulator41-90152026-02-04
05056785302445Bonn Forceps Straight 0.12mm Toothed, O/L 106mm10-11082025-09-19
05056785303336Connor Wand41-4013BNS2026-01-26
05056785303343Connor Wand41-4013BNS2026-01-26
05056785303251Cataract Instrument Pack - UCM67-00302025-12-11
05056785303268Cataract Instrument Pack - UCM67-00302025-12-11
05056785302698Lenticule Removal Forceps, Serrated Jaw, Direct Action11-90022025-11-14
05056785302711Lenticule Extraction Forceps, Serrated Jaw, Cross Action11-90042025-11-14
05056785302735ICL Loading Forceps, Smooth Jaw, Direct Action11-90012025-11-14
05056785302759ICL Loading Forceps, Smooth Jaw, Cross Action11-90032025-11-14
05056785303015Cataract Inst Set - Spokane Anderson67-00282025-11-12
05056785303039Cataract Inst Set - Spokane Adams67-00292025-11-12
05056785302704Lenticule Removal Forceps, Serrated Jaw, Direct Action11-90022025-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770498758Bausch + LombBausch & Lomb IncorporatedHMQ2025-08-04
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00810123483662Vortex Surgical Inc.Vortex Surgical, Inc.HMQ2025-04-18
00810123483655Vortex Surgical Inc.Vortex Surgical, Inc.HMQ2025-04-18
00194613086534MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
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00194613040918MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040925MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040932MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15