FDA.report

Synergetics

Primary DI
20841305106936
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
55.36.251E
Catalog number
55.36.251E
Device description
25ga Inverted Extendable Directional Laser Probe, Vitra™/Supra™
Published
2016-08-30
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

Related Records

Product Codes

CodeName
HQBPHOTOCOAGULATOR AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
HQBPhotocoagulator And AccessoriesOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20841305106936PrimaryGS10
10841305100456Unit of UseGS10

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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

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