FDA.reportPublic FDA data

LED SLIMLINE STUDENT KIT

Primary DI
05055272712644
Brand
LED SLIMLINE STUDENT KIT
Company
KEELER LIMITED
Model
1205-P-2007
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055272712644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055272712644050552727126445055272712644

GMDN Terms#

Term, Definition table
TermDefinition
Indirect binocular ophthalmoscope, battery-poweredA battery-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; the batteries may be incorporated, or the power supplied via an electrical cable from an external battery pack.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210164398
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
05055272719674532nm LIO1205-P-21302021-07-20
05055272720328514/810nm LIO1205-P-21702021-07-20
05055272720380577nm LIO1205-P-21802021-07-20
050552727199263.6V PROFESSIONAL OPHTH IN CASE1128-P-1014-5002020-02-27
050552727199333.6V SPECIALIST OPHTH IN CASE1132-P-1157-5002020-02-27
050552727199403.6V PROFESSIONAL STREAK RETINOSCOPE IN CASE1302-P-1011-5002020-02-27
050552727199573.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASE1302-P-1014-5002020-02-27
05055272719964US PROFESSIONAL LED STUDENT KIT-SLIM1427-P-1100-5002020-02-27
05055272719971US PROFESSIONAL COMPLETE LED STUDENT SET1427-P-1127-5002020-02-27
050552727199883.6V PRACTITIONER/ FIBRE-OPTIC DIAGNOSTIC SET1729-P-1024-5002020-02-27
05055272719995SLIMLINE RECHARGEABLE HANDLE & BATTERY1911-P-1201-5002020-02-27
05055272720007RECHARGEABLE HANDLE & REFRACTION STAND ADAPTOR1911-P-1244-5002020-02-27
05055272720038US LED SPECIALIST/ RETINOSCOPE STUDENT SET1427-P-1130-5002020-02-27
05055272701204API 2/2 IN CARTON1204-P-30362016-08-26
05055272700641Pocket Set 2.8v1102-P-10412016-08-16
050552727007643.6V PROFESSIONAL OPHTH HEAD ONLY1128-P-10042016-08-26

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Primary DI, Brand, Company table
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