Synergetics 56.02P

GUDID 10841305100692

Endo Illuminator

SYNERGETICS USA, INC.

Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use
Primary Device ID10841305100692
NIH Device Record Key6747c7c0-5260-4275-bb66-2f6b0fc3e7a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynergetics
Version Model Number56.02P
Catalog Number56.02P
Company DUNS021056726
Company NameSYNERGETICS USA, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS110841305100692 [Primary]
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution
GS120841305107179 [Package]
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator
MPAEndoilluminator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [Synergetics]

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20841305110810"The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 1.5mm Ti
20841305110797"The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 1mm Tip,
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2084130511043823ga Inverted Extendable Directional Laser Probe
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2084130511039127ga VersaVIT 2.0™ Core Essentials Biopsy Procedure Pack
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2084130511033920ga VersaVIT 2.0™ Procedure Pack with PHOTON™ Wide Field Illuminator
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2084130511027827ga VersaVIT 2.0™ Core Essentials Procedure Pack
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2084130511021627ga Vivid Chandelier - Stellaris PC
2084130511019325ga Vivid Chandelier - Stellaris PC
2084130511017925ga Stellaris PC Diffuse Wide Field Endoilluminator
2084130511015523ga Stellaris PC Diffuse Wide Field Endoilluminator
2084130511013127ga Stellaris PC Midfield Endoilluminator
2084130511011725ga Stellaris PC Midfield Endoilluminator
2084130511009423ga Stellaris PC Midfield Endoilluminator
2084130510998225ga Stellaris PC Vitrectomy Probe
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2084130510971527ga VersaVIT 2.0™ Procedure Pack with PHOTON™ Mid-Field Illuminator
2084130510969225ga VersaVIT 2.0™ Procedure Pack with Illuminated Directional Laser Probe
2084130510959323ga VersaVIT 2.0™ Procedure Pack with Illuminated Directional Laser Probe
2084130510956227ga VersaVIT™ Vitrectomy Probe, 6ft
2084130510955520ga VersaVIT™ Vitrectomy Probe, 6ft
2084130510949425ga Illuminated Directional II Laser Probe
2084130510948723ga Illuminated Directional II Laser Probe
20841305108848Stiff 25ga Tano Diamond Dusted Membrane Scraper (DDMS™)
2084130510883123ga Tano Diamond Dusted Membrane Scraper (DDMS™)
2084130510852725ga VersaVIT 2.0™ Vitrectomy Probe
2084130510851023ga VersaVIT 2.0™ Vitrectomy Probe
2084130510850325ga VersaVIT 2.0™ Procedure Pack with PHOTON™ Wide Field Illuminator
2084130510849725ga VersaVIT 2.0™ Procedure Pack with Mid-Field Illuminator
2084130510848025ga VersaVIT 2.0™ Core Essentials Procedure Pack

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