FDA.reportPublic FDA data

Synergetics

Primary DI
20841305106523
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
55.21.23
Catalog number
55.21.23
Device description
23ga Straight Laser Probe
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20841305106523PrimaryGS10
10841305100043Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084130510652320841305106523
1084130510004310841305100043

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
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20841305107599Synergetics18067180672020-09-18
20841305107636Synergetics31.0231.022020-09-18
20841305107643Synergetics41.0041.002020-09-18
20841305107711Synergetics16579165792020-09-18
20841305107735Synergetics12.06.2512.06.252020-09-18
20841305107780Synergetics17570175702017-12-30
20841305107797Synergetics17580175802020-09-18
20841305107803Synergetics17680176802020-09-18
20841305107810Synergetics19020190202020-09-18
20841305107896Synergetics30.08.2330.08.232020-09-18
20841305107902Synergetics30.08.2530.08.252020-09-18
20841305107919Synergetics30.08.2730.08.272020-09-18
20841305107926Synergetics30.1030.102020-09-18
20841305107933Synergetics30.10.2330.10.232020-09-18
20841305107940Synergetics30.11.2330.11.232020-09-18
20841305107957Synergetics30.32.2330.32.232020-09-18
20841305107964Synergetics30.32.2530.32.252020-09-18
20841305107971Synergetics30.80.2530.80.252020-09-18
20841305107988Synergetics30.9030.902020-09-18
20841305107995Synergetics40.01-640.01-62020-09-18

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