FDA.reportPublic FDA data

Kratz Plastic Mechanical Speculum

Primary DI
05056785302971
Brand
Kratz Plastic Mechanical Speculum
Company
BLINK MEDICAL LIMITED
Model
31-3005
Published
2026-02-04
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
HNCSpecula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056785302988PackageGS110In Commercial Distribution
05056785302971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056785302988050567853029885056785302988
05056785302971050567853029715056785302971

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, single-useA self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. 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
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
05056785302728Lenticule Extraction Forceps, Serrated Jaw, Cross Action11-90042025-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047900174Kratz-Barraquer Wire SpeculumA1 Medical GmbHHNC2026-05-29
04251047900655Lieberman Eye SpeculumA1 Medical GmbHHNC2026-05-29
04251047900679Lieberman Eye SpeculumA1 Medical GmbHHNC2026-05-29
04251047900686Lieberman Eye SpeculumA1 Medical GmbHHNC2026-05-29
04251047932373Mod. Krumeich Eye SpeculumA1 Medical GmbHHNC2026-05-29
08175700102636Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-10
08175700102643Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-10
08175700102650Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-10
08175700100489Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
08175700100571Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
08175700102605Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
08175700102612Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
08175700102629Ophthalmic SpeculumAURORA SURGICAL, LLCHNC2024-01-09
G346E12150Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2023-02-13
G346E1253R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-19
G346E1254L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-19
G346E1254R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-19
G346E11250Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E11260Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E11440Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E11490Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E11560Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12010Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12020Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12030Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12050Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12060Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12070Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12100Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16
G346E12210Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2022-12-16