FDA.reportPublic FDA data

SMARTPACK

Primary DI
05055272702874
Brand
SMARTPACK
Company
KEELER LIMITED
Model
1945-P-1001
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HLJOphthalmoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055272702874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055272702874050552727028745055272702874

GMDN Terms#

Term, Definition table
TermDefinition
Indirect binocular ophthalmoscope, line-poweredA mains electricity (AC-powered), ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. It typically consists of a main light to illuminate the interior of the eyeball, a system of lenses and filters and an illuminator beam to eliminate reflexes. Also called a binocular indirect ophthalmoscope (BIO), it produces images that better overcome large refractive errors and subtle colour differences. It can be mounted on a headband or spectacle frames and the power is run through a transformer to reduce this to low-voltage.

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
05055272711241Vantage Plus Digital Kit1205-P-50102016-08-16
05055272711265Vantage Plus LED Slimline & Charger1205-P-10202016-08-16
05055272711272VANTAGE+ LED SLIMLINE KIT A1205-P-10162016-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M368122731LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
M368122741LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
00192896009509HEINE - BETA R HANDLESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009516HEINE - LITHIUM ION BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009523HEINE MPACK MINI SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009530HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009547HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009554HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009561HEINE HC 50 CONNECTING CORDSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009578HEINE MPACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009585HEINE MPACK COMPLETESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009592HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00634782089221Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089238Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089252Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089276Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089290Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089313Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089320Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782088910Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088934Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088941Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088958Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088965Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088972Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088989Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088996Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087753Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087760Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087784Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12