FDA.report

A.C. Maintainers

Primary DI
15056030400404
Brand
A.C. Maintainers
Company
STERIMEDIX LIMITED
Model
M2657-02/10
Catalog number
M2657
Device description
20g ACM Lewicky
Published
2024-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MEDSterilant, Medical Devices

Product Code Classifications

CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
65056030400409PrimaryGS10
15056030400404Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
6505603040040965056030400409
1505603040040415056030400404

GMDN Terms

TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
504799313
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05056030400148Anaesthetic Needles0641-03TM06412026-03-04
05056030400155Anaesthetic Needles0641A-03/YM06412026-03-04
05056030400025Anaesthetic Needles0275-03/YM02752024-10-07
25056030401804Bimanual I/A SystemsM5537-02/5M55372025-08-22
25056030400999Refractive CannulaeM2801-02/10 M28012025-03-25
25056030401019Vitreoretinal CannulaeM4449-02/10M44492025-03-25
25056030401484Vitreoretinal HandpiecesM4503-02/5M45032025-03-25
35056030400996Vitreoretinal CannulaeM4447-02/10M44472025-03-25
35056030401009Vitreoretinal CannulaeM4478-02/10M44782025-03-25
55056030400969Hydrodissection CannulaeM3992-02M39922025-02-17
15056030401746Bimanual I/A SystemsM5531-02/5M55312025-01-30
35056030400781Hydrodissection CannulaeM3907-02/10M39072024-12-09
25056030401392Handpieces and CannulaeM4495-02/5M44952024-12-09
15056030400244Anterior Chamber Maintenance CannulaeM2273B-02/10M2273B2024-12-09
15056030400541Formed Irrigating CystotomesM3001-02/10M30012024-12-09
25056030402399Lachrymal CannulaeM9277-02/10M92772024-12-09
35056030401740Bimanual I/A Systems5531NS-02/YM55312024-11-08
25056030403020Handpieces and CannulaeM4504-02/5M45042024-10-18
15056030400534Formed Capsularhexis CystotomesM3000G-02SP/10M3000G2024-10-18
25056030400364Viscoelastic CannulaeM2639A-02/10M2639A2024-10-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05056030400148Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
05056030400155Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
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10705037041596CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041602CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041664CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
20705037048752AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10885862658159EXACTECHExactech, Inc.MED2025-11-14
10885862658180EXACTECHExactech, Inc.MED2025-11-14
00857635006040Aldahol 1.8ALDEN MEDICAL LLCMED2025-09-12
25056030401804Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-08-22
25056030400999Refractive CannulaeSTERIMEDIX LIMITEDMED2025-03-25
25056030401019Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
25056030401484Vitreoretinal HandpiecesSTERIMEDIX LIMITEDMED2025-03-25
35056030400996Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
35056030401009Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
55056030400969Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2025-02-17
15056030401746Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-01-30
35056030400781Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2024-12-09
25056030401392Handpieces and CannulaeSTERIMEDIX LIMITEDMED2024-12-09
15056030400244Anterior Chamber Maintenance CannulaeSTERIMEDIX LIMITEDMED2024-12-09
15056030400541Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2024-12-09
25056030402399Lachrymal CannulaeSTERIMEDIX LIMITEDMED2024-12-09
35056030401740Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2024-11-08
25056030403020Handpieces and CannulaeSTERIMEDIX LIMITEDMED2024-10-18
15056030400534Formed Capsularhexis CystotomesSTERIMEDIX LIMITEDMED2024-10-18
25056030400364Viscoelastic CannulaeSTERIMEDIX LIMITEDMED2024-10-18
05056030400025Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2024-10-07
05056030400162Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2024-10-07