FDA.reportPublic FDA data

MST A1 Lt Blue Silicone Sleeve and MST plastic wrench

Primary DI
00844685003297
Brand
MST A1 Lt Blue Silicone Sleeve and MST plastic wrench
Company
MICROSURGICAL TECHNOLOGY, INC.
Model
SPK-0009-1
Catalog number
SPK-0009-1
Published
2018-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
KYGDevice, Irrigation, Ocular Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYGDevice, Irrigation, Ocular SurgeryOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844685003297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844685003297008446850032978446850032970844685003297

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA 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. 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 reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Radiation Sterilization""]"
Moist Heat or Steam Sterilization;Radiation Sterilization

Regulatory Flags#

DUNS number
097824130
Device count
1
Premarket exempt
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
00844685001279Duet Forceps HandleDFH-0007DFH-00072018-09-18
00844685001408MST 360° Forceps HandleDFH-0021DFH-00212018-09-18
00844685001460MST Touch Forceps HandleDFH-0028DFH-00282018-09-18
00844685005536Handle Assy, Single-Use, PackagedDFH-1028DFH-10282018-09-18
00844685014309ArcDuo, Guarded Depth Paired Ophthalmic Knife 10mmARC-00012025-10-10
00844685014316ArcDuo, Guarded Depth Paired Ophthalmic Knife 9mmARC-00022025-10-10
108446850055401X, 25g Ahmed Micro-GraspersAMG-1001AMG-10012018-09-18
108446850055641X 23g MicroHolding ForcepsDFH-1019DFH-10192018-09-18
1084468500630125g 1X Ahmed Micro-Graspers lgr tpsDFH-1034DFH-10342018-09-18
00844685011124Accutome SurgicalAF41202023-03-14
00844685011131Accutome SurgicalAF4130 2023-03-14
0084468500123123g Ahmed Micro-Tying ForcepsDFH-0003DFH-00032018-09-18
00844685001248Ahmed Schlemm's Canal, Head, 23GaDFH-0004DFH-00042018-09-18
0084468500129323g Ahmed Micro-Graspers, Curved ShaftDFH-0009DFH-00092018-09-18
0084468500131623g Ahmed Micro-Graspers, Straight ShaftDFH-0011DFH-00112018-09-18
0084468500133023g MST Tissue Grasper ForcepsDFH-0014DFH-00142018-09-18
0084468500134723g Verisyse Enclavation ForcepsDFH-0015DFH-00152018-09-18
0084468500135423g Verisyse Lens Holding ForcepsDFH-0016DFH-00162018-09-18
00844685001361MST ICL Grasping ForcepsDFH-0017DFH-00172018-09-18
0084468500137823g MST Micro-Holding ForcepsDFH-0019DFH-00192018-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770636105Bausch + LombBausch & Lomb IncorporatedKYG2026-04-30
B090MT2020MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
B090MT2021MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
G22312647930Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2025-11-05
00757770636266Bausch + LombBausch & Lomb IncorporatedKYG2025-08-05
00757770483402Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
00757770492329Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
B090MT20000MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
08052276027290Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2025-06-04
00757770406463Bausch + LombBausch & Lomb IncorporatedKYG2024-11-21
00194613022938MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613022945MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023959MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023973MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044817MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044824MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613046101MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060091MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060633MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613088057MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613090340MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
G223IAT3S45Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-06-17
G223IAT3S450Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-05-23
08052276026354Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08052276026361Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
08052276026378Passive Reservoir AKTIVE SRLKYG2024-01-11
08052276026385Active ReservoirAKTIVE SRLKYG2024-01-11
08052276027450Dual Bore Cannula 27GAKTIVE SRLKYG2024-01-11