FDA.reportPublic FDA data

Toric Alignment Marker, 3, 6, 9 O'Clock

Primary DI
05060480408265
Brand
Toric Alignment Marker, 3, 6, 9 O'Clock
Company
BLINK MEDICAL LIMITED
Model
91-6001
Published
2022-06-30
Public version status
Update
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
HMRMarker, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060480402768PackageGS110In Commercial Distribution
05060480408265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060480402768050604804027685060480402768
05060480408265050604804082655060480408265

GMDN Terms#

Term, Definition table
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 table
Method

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

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Primary DI, Brand, Company table
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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
G22312270490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2025-11-05
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
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00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04