Synergetics

Primary DI
20841305112142
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
BL5827D
Catalog number
BL5827D
Device description
27ga Stellaris PC Diffuse Wide Field Endoilluminator
Published
2020-05-31
Public version status
New
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
HJMTransilluminator, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJMTransilluminator, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841305112142PackageGS16In Commercial Distribution
10841305112138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084130511214220841305112142
1084130511213810841305112138

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
1
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

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
04053755202973FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJM2025-07-17
00810123483167Vortex Surgical Inc.Vortex Surgical, Inc.HJM2025-04-18
00810123483150Vortex Surgical Inc.Vortex Surgical, Inc.HJM2025-04-18
0063230700235925GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
0063230700236627GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
0063230700237323GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
1063230700235625GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
1063230700236327GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
1063230700237023GA Midfield Endoillumination ProbePeregrine Surgical, LlcHJM2024-09-24
04053755119943OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJM2022-12-21
04053755120109OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJM2022-12-21
04053755200429FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJM2022-12-21
04053755199679WALL TRANSFORMER EN 200Heine Optotechnik GmbH & Co. KGHJM2022-12-12
04053755199686WALL TRANSFORMER EN 200-1Heine Optotechnik GmbH & Co. KGHJM2022-12-12
10812594013079NeoGlo® DisposableNeotech Products LLCHJM2021-05-20
10812594013086NeoGlo® DisposableNeotech Products LLCHJM2021-05-20
00812594013072NeoGlo DisposableNEOTECH PRODUCTS, INC.HJM2021-05-20
00812594013089NeoGlo DisposableNEOTECH PRODUCTS, INC.HJM2021-05-20
10841305112138SynergeticsSYNERGETICS USA, INC.HJM2020-05-31
07290109140766Acculite™ EndoOcular®LUMENIS INC.HJM2016-09-25
17290109140763Acculite™  EndoOcular®LUMENIS INC.HJM2016-09-25
B396050080VT0ESIFTT MEDICAL, INC.HJM2016-09-16
B396050100VT0ESIFTT MEDICAL, INC.HJM2016-09-16
B3960501020ESIFTT MEDICAL, INC.HJM2016-09-16
B3960501120ESIFTT MEDICAL, INC.HJM2016-09-16
B396MSK1116050ESIFTT MEDICAL, INC.HJM2016-09-16
07290109140759Acculite™ EndoOcular®LUMENIS INC.HJM2016-09-12
17290109140756Acculite™  EndoOcular®LUMENIS INC.HJM2016-09-12
05055272707794Finhoff Transilluminator 2.8vKEELER LIMITEDHJM2016-08-16
05055272715140Transilluminator 3.5v in cartonKEELER LIMITEDHJM2016-08-16