FDA.reportPublic FDA data

TrabEx Pro

Primary DI
00844685009381
Brand
TrabEx Pro
Company
MICROSURGICAL TECHNOLOGY, INC.
Model
600050-01
Catalog number
600050-01
Device description
The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.
Published
2022-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRHPump, Infusion, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRHPump, Infusion, OphthalmicGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213173000TrabEx ProMicrosurgical Technologies, Inc.2022-06-08MRH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844685009381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844685009381008446850093818446850093810844685009381

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, single-useA sterile, hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
097824130
Device count
1
Lot or batch
true
Expiration date on label
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
00893872001653iTrack 250ENova Eye, Inc.MRH2026-05-05
00858027006594OMNI Edge Surgical SystemSight Sciences, Inc.MRH2025-03-06
00892064002362VIA360 Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2025-02-18
00892064002102Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2025-02-15
00892064002072Streamline Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2023-11-01
00858027006433OMNI Surgical SystemSight Sciences, Inc.MRH2023-10-17
00858027006525OMNI Surgical SystemSight Sciences, Inc.MRH2022-08-22
00853704002456iPRIMEGLAUKOS CORPORATIONMRH2022-05-13
00892064002010Streamline® Surgical SystemNEW WORLD MEDICAL, INCORPORATEDMRH2021-11-01
00858027006358OMNI PLUSSight Sciences, Inc.MRH2020-10-30
00858027006372OMNI(R) Surgical System (US)Sight Sciences, Inc.MRH2020-06-01
00858027006334OMNI Surgical System (US)Sight Sciences, Inc.MRH2019-10-25
00893872001585ViscoInjectorNova Eye, Inc.MRH2019-01-28
00858027006310OMNI Surgical System (US)Sight Sciences, Inc.MRH2018-03-16
00858027006013VISCO(TM)360 Viscosurgical SystemSight Sciences, Inc.MRH2016-09-22
00893872001059iTrack 250ANova Eye, Inc.MRH2016-09-15
00853480006013Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
00853480006242Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
10853480006010Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14
10853480006249Viscous Fluid PackESCALON MEDICAL CORP.MRH2016-01-14