FDA.report

NA

Primary DI
00697077001995
Brand
NA
Company
Amico Diagnostic Incorporated
Model
DS-UF1-CLFL-DXX
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ERAOtoscope

Product Code Classifications

CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00697077001995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00697077001995006970770019956970770019950697077001995

GMDN Terms

TermDefinition
Direct ophthalmoscope, line-poweredA mains electricity (AC-powered), hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of, a built-in light that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single hole through which the examiner will view, and a dial containing several lenses of different powers that can be alternated by the examiner whilst viewing. It produces an upright, or unreversed, image of approximately 15 times magnification. The power is run through a transformer to reduce this to low-voltage.

Sterilization Methods

Method

Contacts

PhoneEmail
1-877-264-2697info@amico-accessories.com

Regulatory Flags

DUNS number
203163290
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
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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00697077003074Amico Diagnostic CuffCR2-LF13W-2BV2025-04-04
00697077002633Amico Diagnostic CuffCR2-LF07O-2BVSM2020-11-16
00697077003043DS-UDN-CLFL-DAIDS-UDN-CLFL-DAI2024-07-11
00697077003050Amico Diagnostic, Inc.DS-ULG-CLFL-DAO2024-09-18
00697077003036NAAM-GL-LF21182024-06-24
00697077003029NADS-UV1-CLFL-DXX2024-05-02
00697077002237NADS-UHM-CHFH-DAX2023-07-27
00697077002985NACR2-LF09G-2SF2023-07-27
00697077002992NACR2-LF07O-2SF2023-07-27
00697077003005NACR2-LF10B-2SF2023-07-27
00697077003012NACR2-LF12M-2SF2023-07-27
00697077002978NACR2-LFMLT-2BVSF2023-07-05
00697077002961NACR2-LF10B-2BVSM2023-04-18
00697077002923NADS-ELG-CLFL-DAX2022-02-02
00697077002930NADS-EDM-CLFL-XXX2022-02-02
00697077002916NADS-UF2-CLFL-DAI2021-09-03
00697077002909NADS-UF2-CHFH-DAX2021-06-22
00697077002893NATP-V-OP92021-04-05

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