FDA.reportPublic FDA data

Synergetics

Primary DI
10841305111506
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
57.31
Catalog number
57.31
Device description
Synerfit™ Single Fiber Adapter for Alcon® Constellation®
Published
2020-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ONEPowered light based non-laser surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONEPowered Light Based Non-Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841305111506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084130511150610841305111506

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic light sourceAn electrically-powered, noninvasive device designed to produce light of high intensity, often called cold light, for ophthalmic examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., fibreoptic probes and micro light-conducting ophthalmic instruments that provide intraocular illumination).

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
1
DM exempt
true
Premarket exempt
true
Lot or batch
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
08057622080004MTONE EVOM & T SRLONE2025-04-15
08057622080011MTONE EVOM & T SRLONE2025-04-15
08057622080028MT ONEM & T SRLONE2025-04-15
08057622080035MT ONEM & T SRLONE2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONE2025-04-15
10841305105192SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305105338SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305105567SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305106144SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305109916SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111087SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111483SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111490SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111513SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111520SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
10841305111698SynergeticsSYNERGETICS USA, INC.ONE2020-09-18
00860564000317Spectrum Laser/IPLROHRER AESTHETICS, LLCONE2016-09-22