FDA.reportPublic FDA data

Synergetics

Primary DI
20841305106820
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
55.26.25L
Catalog number
55.26.25L
Device description
25ga Directional Laser Probe, Lumenis
Published
2016-09-16
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
HQBPhotocoagulator and accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQBPhotocoagulator And AccessoriesOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841305106820PrimaryGS10
10841305100340Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084130510682020841305106820
1084130510034010841305100340

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). 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

Regulatory Flags#

DUNS number
021056726
Device count
12
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
10840096215301XLEND23MULTIFLEXKATALYST SURGICAL LLCHQB2025-06-24
10840096215318XLEND25MULTIFLEXKATALYST SURGICAL LLCHQB2025-06-24
00810123483518Vortex Surgical Inc.Vortex Surgical, Inc.HQB2025-04-19
00810123483549Vortex Surgical Inc.Vortex Surgical, Inc.HQB2025-04-18
00810123483532Vortex Surgical Inc.Vortex Surgical, Inc.HQB2025-04-18
00810123483525Vortex Surgical Inc.Vortex Surgical, Inc.HQB2025-04-18
1063230700232527GA Curved Illuminating Laser Probe - DORCPeregrine Surgical, LlcHQB2024-09-24
0063230700233527GA Curved Illuminating Laser Probe - AlconPeregrine Surgical, LlcHQB2024-09-24
1063230700234927GA Curved Illuminating Laser Probe - IridexPeregrine Surgical, LlcHQB2024-09-24
00810123480067Vortex Surgical IncVortex Surgical, Inc.HQB2023-02-03
00810123480074Vortex Surgical IncVortex Surgical, Inc.HQB2023-02-03
00810123480081Vortex Surgical IncVortex Surgical, Inc.HQB2023-02-03
00810123480098Vortex Surgical IncVortex Surgical, Inc.HQB2023-02-03
00810123480005Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480012Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480029Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480036Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480043Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480050Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480104Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480111Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480128Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480135Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
00810123480142Vortex Surgical IncVortex Surgical, Inc.HQB2022-11-23
M735A5026005NAOPHTHALMED LLCHQB2022-09-22
M735A5027005NAOPHTHALMED LLCHQB2022-09-22
M735A5036005NAOPHTHALMED LLCHQB2022-09-22
M735A5037005NAOPHTHALMED LLCHQB2022-09-22
M735A5076005NAOPHTHALMED LLCHQB2022-09-22
M735A5077005NAOPHTHALMED LLCHQB2022-09-22