FDA.reportPublic FDA data

Transilluminator 3.5v in carton

Primary DI
05055272715140
Brand
Transilluminator 3.5v in carton
Company
KEELER LIMITED
Model
2903-P-7001
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJMTransilluminator, Ac-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893170000VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)Keeler Instruments, Inc.1989-06-05HJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055272715140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055272715140050552727151405055272715140

GMDN Terms#

Term, Definition table
TermDefinition
Skin transilluminator, battery-poweredA hand-held, battery-powered device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210164398
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055272711777PSL One3010-P-20012016-08-08
05055272707503ADAPTOR FOR F SIZE CO2 CYLINDER2508-P-70162025-03-26
05055272707527ADAPTOR FOR F SIZE N2O CYLINDER2508-P-70182025-03-26
05055272721424DORC CRYOSTAR ADAPTOR2509-P-80362025-03-26
05055272721431ERBE ERBOKRYO ADAPTOR2509-P-80372025-03-26
050552727199263.6V PROFESSIONAL OPHTH IN CASE1128-P-1014-5002020-02-27
050552727007643.6V PROFESSIONAL OPHTH HEAD ONLY1128-P-10042016-08-26
050552727007712.8V PROFESSIONAL OPHTH IN CASE1128-P-10132016-08-26
050552727007883.6V PROFESSIONAL OPHTH IN CASE1128-P-10142016-08-26
050552727009003.6V SPECIALIST OPHTH IN CASE1132-P-11572016-08-26
05055272701204API 2/2 IN CARTON1204-P-30362016-08-26
05055272701341API 2/2 Kit 11204-P-31002016-08-16
05055272702621POWER PACK IN CARTON (USA)1919-P-10022016-08-26
05055272702669POWER PACK ASSY1919-P-51192016-08-26
05055272702768LITHIUM MINI CHARGER IN CARTON1941-P-13412016-08-26
05055272702775LITHIUM DOUBLE CHARGER1941-P-13682016-08-26
05055272702782WIRELESS INDIRECT CHARGER IN CARTON1941-P-13842016-08-26
05055272702874SMARTPACK1945-P-10012016-08-26
05055272711241Vantage Plus Digital Kit1205-P-50102016-08-16
05055272711265Vantage Plus LED Slimline & Charger1205-P-10202016-08-16

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
20841305112142SynergeticsSYNERGETICS 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