FDA.reportPublic FDA data

Synergetics

Primary DI
20841305109401
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
31.01
Catalog number
31.01
Device description
Replacement Backflush Reservoir
Published
2019-04-02
Public version status
Update
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
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841305109401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084130510940120841305109401

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cannulation set, single-useA collection of non-powered devices intended to be used to create a channel through the sclera for posterior segment ophthalmic surgery. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021056726
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841305101118Synergetics18067180672020-09-18
10841305101064Synergetics18060180602020-05-31
10841305101071Synergetics18061180612020-05-31
10841305101088Synergetics18063180632020-05-31
10841305101095Synergetics18064180642020-05-31
10841305101125Synergetics18069180692020-05-31
10841305101132Synergetics18069W18069W2020-05-31
10841305101156Synergetics31.0231.022020-09-18
10841305101163Synergetics41.0041.002020-09-18
10841305101231Synergetics16579165792020-09-18
10841305101255Synergetics12.06.2512.06.252020-09-18
10841305101309Synergetics17570175702017-12-30
10841305101316Synergetics17580175802020-09-18
10841305101323Synergetics17680176802020-09-18
10841305101330Synergetics19020190202020-09-18
10841305101415Synergetics30.08.2330.08.232020-09-18
10841305101422Synergetics30.08.2530.08.252020-09-18
10841305101439Synergetics30.08.2730.08.272020-09-18
10841305101446Synergetics30.1030.102020-09-18
10841305101453Synergetics30.10.2330.10.232020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
G22312643590Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G223140461200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G346EEC0330Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMX2026-03-18
G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
G412CA14030MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14040MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14050MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14060MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14070MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14080MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14090MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14100MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14110MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14120MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14130MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14140MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14150MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14160MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14170MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14180MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14190MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14200MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14210MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14220MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14230MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14240MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14250MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14260MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14270MR PHACOCrestpoint Management LimitedHMX2025-05-27