FDA.reportPublic FDA data

Scleral Markers

Primary DI
55056030402291
Brand
Scleral Markers
Company
STERIMEDIX LIMITED
Model
7500NS-02/100/Y
Catalog number
M7500NS
Device description
3.5 x 4mm Scleral Marker
Published
2024-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEDSterilant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55056030402291PrimaryGS10
45056030402294Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5505603040229155056030402291
4505603040229445056030402294

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, single-useA manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
504799313
Device count
100
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056030403057Backflush Aspiration HandpiecesM4530-02/5M45302026-07-21
05056030403613Hydrodissection Cannulae2273E-02/10M2273E2026-07-21
15056030400688Formed Irrigating Cystotomes02SP/10M3629A2026-06-24
25056030403785Formed Irrigating Cystotomes02SP/10M36022026-06-24
25056030403792Formed Irrigating Cystotomes02SP/10M3626A2026-06-24
25056030403808Formed Irrigating Cystotomes02SP/10M36272026-06-24
25056030403815Formed Irrigating Cystotomes02SP/10M3627A2026-06-24
25056030403822Formed Irrigating Cystotomes02SP/10M36302026-06-24
25056030403839Formed Irrigating Cystotomes02SP/10M36292026-06-24
25056030403846Formed Irrigating Cystotomes02SP/10M3615A2026-06-24
25056030403853Formed Irrigating Cystotomes02SP/10M36152026-06-24
25056030403860Formed Irrigating Cystotomes02SP/10M3610S2026-06-24
25056030403877Formed Irrigating Cystotomes02SP/10M3610C2026-06-24
25056030403884Formed Irrigating Cystotomes02SP/10M3000E2026-06-24
25056030403891Formed Irrigating Cystotomes02SP/10M36102026-06-24
25056030403907Formed Irrigating Cystotomes02SP/10M3610B2026-06-24
25056030403914Formed Irrigating Cystotomes02SP/10M3000D2026-06-24
25056030403921Formed Irrigating Cystotomes02SP/10M3000F2026-06-24
25056030403938Formed Irrigating Cystotomes02SP/10M3000G2026-06-24
25056030403945Formed Irrigating Cystotomes02SP/10M30012026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056030403057Backflush Aspiration HandpiecesSTERIMEDIX LIMITEDMED2026-07-21
05056030403613Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2026-07-21
15056030400688Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403785Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403792Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403808Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403815Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403822Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403839Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403846Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403853Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403860Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403877Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403884Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403891Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403907Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403914Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403921Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403938Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403945Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403952Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030404089Anterior CannulaSTERIMEDIX LIMITEDMED2026-02-24
10705037048755AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10885862658166EXACTECHExactech, Inc.MED2025-11-14
10885862658173EXACTECHExactech, Inc.MED2025-11-14
10885862658197EXACTECHExactech, Inc.MED2025-11-14
10885862658203EXACTECHExactech, Inc.MED2025-11-14
10885862658210EXACTECHExactech, Inc.MED2025-11-14
10885862658227EXACTECHExactech, Inc.MED2025-11-14
10885862658234EXACTECHExactech, Inc.MED2025-11-14