FDA.report

Adlite™ Plus

Primary DI
00634782546212
Brand
Adlite™ Plus
Company
AMERICAN DIAGNOSTIC CORP
Model
358WP
Catalog number
358WP
Device description
ADLITE Plus Disp Penlight,22/cyl, White w/ pupil
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications

CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782546212PackageGS112In Commercial Distribution
00634782046408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782546212006347825462126347825462120634782546212
00634782046408006347820464086347820464080634782046408

GMDN Terms

TermDefinition
Hand-held examination/treatment lightA small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags

DUNS number
108999095
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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