FDA.reportPublic FDA data

Bi-Manual, 21 Gauge, Straight Open End, Irrigation

Primary DI
00844685002733
Brand
Bi-Manual, 21 Gauge, Straight Open End, Irrigation
Company
MICROSURGICAL TECHNOLOGY, INC.
Model
BI-001
Catalog number
BI-001
Published
2018-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KYGDevice, Irrigation, Ocular Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
KYGDevice, Irrigation, Ocular SurgeryOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844685002733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844685002733008446850027338446850027330844685002733

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
097824130
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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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
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00844685008391Snyder RulerSR-1000SR-10002024-07-05
00844685009442Accutome SurgicalAF01252024-07-05
00844685009459Accutome SurgicalAF01302024-07-05
00844685009466Accutome SurgicalAF01402024-07-05
00844685009480Accutome SurgicalAF0290 AI2024-07-05
00844685010707Accutome SurgicalAF02902024-07-05
00844685010714Accutome SurgicalAF0290 A2024-07-05
00844685010721Accutome SurgicalAF0290K2024-07-05
00844685010738Accutome SurgicalAF0290L2024-07-05
00844685010745Accutome SurgicalAF0290M2024-07-05
00844685010752Accutome SurgicalAF0290M T2024-07-05
00844685010776Accutome SurgicalAF02922024-07-05
00844685010783Accutome SurgicalAF02992024-07-05
00844685011124Accutome SurgicalAF41202023-03-14
00844685011131Accutome SurgicalAF4130 2023-03-14
00844685008636MST Scleral IOL FixationSFP-1001SFP-10012023-03-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B090MT2021MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
00757770636266Bausch + LombBausch & Lomb IncorporatedKYG2025-08-05
00757770483402Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
00757770492329Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
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
08058340220710Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08058340220727Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
08058340220734Passive Reservoir AKTIVE SRLKYG2024-01-11
08058340220741Active ReservoirAKTIVE SRLKYG2024-01-11
08056477557518Dual Bore Cannula 27GAKTIVE SRLKYG2024-01-11
08056477559598Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2023-12-19
08058340220994Dual Bore Cannula 20GAKTIVE SRLKYG2023-12-19
08058340221007Dual Bore Cannula 23GAKTIVE SRLKYG2023-12-19
08058340221014Dual Bore Cannula 25GAKTIVE SRLKYG2023-12-19
08056477559604Dual Bore Cannula 25G, 36mmAKTIVE SRLKYG2023-12-19