Synergetics

Primary DI
20841305107520
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
56.55.27P
Catalog number
56.55.27P
Device description
27ga ONE-STEP™ Awh/Tano Chandelier
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

Product Codes#

Code, Name table
CodeName
MPAEndoilluminator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPAEndoilluminatorGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841305107520PrimaryGS10
10841305101040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084130510752020841305107520
1084130510104010841305101040

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fibreoptic light instrument, single-useA sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral 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
00893872001660iLuminNova Eye, Inc.MPA2026-01-09
18717872035496TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
18717872035540TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-04-01
18717872035403Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
1871787203542723 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035441Shielded TotalView Endoillumination Probe, including illuminated scleral depressD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035458TotalView Endoillumination Probe, including illuminated scleral depressor.(23 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035465TotalView Endoillumination Probe, including illuminated scleral depressor.(25 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035472Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035489Endoillumination Probe, including illuminated scleral depressor.(23 gauge / 0.6 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035502TotalView Endoillumination Probe, including illuminated scleral depressor.(20 gaD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035519Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035526Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gaugeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035557Disposable Chandelier fiber (one fiber) with Photon connector and guidance needlD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035564Spaide TotalView Endoillumination Probe, including illuminated scleral depressorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
08717872035574Disposable Chandelier fiber (one fiber) incl. guidance needle. (27 gauge/0.4 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035588TotalView Chandelier for Eckardt cannula system.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
18717872035595Combined 23G Eckardt Multi-Fiber Endoillumination Probe / Chandelier (23 gauge /D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2025-03-31
00893872001608iLuminNova Eye, Inc.MPA2024-07-19
00853386006735Cyclophotocoagulation ProbeLIGHTMED USA INCMPA2023-06-28
18717872009527Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MPA2022-10-04
88719214222099VitreQVitreq B.V.MPA2022-07-30
88719214222112VitreQVitreq B.V.MPA2022-07-30
88719214222136VitreQVitreq B.V.MPA2022-07-30
88719214222150VitreQVitreq B.V.MPA2022-07-30
88719214222174VitreQVitreq B.V.MPA2022-07-30
88719214222198VitreQVitreq B.V.MPA2022-07-30
88719214222211VitreQVitreq B.V.MPA2022-07-30
88719214222235VitreQVitreq B.V.MPA2022-07-30
88719214222259VitreQVitreq B.V.MPA2022-07-30