FDA.report

EyeMag Smart TTL

Primary DI
04049539106889
Brand
EyeMag Smart TTL
Company
Carl Zeiss Meditec AG
Model
000000-2560-293
Published
2025-01-22
Public version status
New
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

Product Codes

CodeName
HOHSpectacle, Operating (Loupe), Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HOHSpectacle, Operating (Loupe), OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049539106889PrimaryGS10

GMDN Terms

TermDefinition
Surgical binoculars, reusableA pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
342228620
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
04049471097153SL 220SL 8002026-01-13
04049539105509INTRABEAM Spherical Sizer Set309121-9100-0002025-06-20
04049539105516INTRABEAM SMART Spherical Applicator309120-9015-002025-05-14
04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539064080INTRABEAM7002025-04-01
04049539066503INTRABEAM SMART Stand66502025-04-01
04049539066435TIVATO® 70066432025-01-22
04049539106018SMARTDRAPE306030-0000-0002025-01-22
04049539106070INTRABEAM SMARTDRAPE326091-0000-0002025-01-22
04049539106094SMARTDRAPE306029-0000-0002025-01-22
04049539106896EyeMag Classic000000-2560-6882025-01-22
04049471095074MEL 90 1900-1092024-12-13
04049471095111VISUMAXVISUMAX 800 or 095112024-12-13
04049539106704Single-use lenses for RESIGHT, MACULA LENS302721-9107-0002024-11-07
04049539106735Single-use lenses for RESIGHT, WIDE-ANGLE LENS302721-9097-0002024-11-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04049584035738BIOM 6 HD Optic Set for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049539106896EyeMag ClassicCarl Zeiss Meditec AGHOH2025-01-22
04049584029447BIOM ready+ 175, for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049584029454BIOM ready+ 200, for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049539101341EyeMag SmartCarl Zeiss Meditec AGHOH2023-11-08
04049539101358EyeMag Pro SCarl Zeiss Meditec AGHOH2023-11-08
04049539101365EyeMag Pro FCarl Zeiss Meditec AGHOH2023-11-08
00842962146866HNM MEDICALHNM STAINLESS, LLC.HOH2023-09-21
00810114911006SurgiTelSurgitelHOH2023-07-25
00810114911013SurgiTelSurgitelHOH2023-07-25
00810114911020SurgiTelSurgitelHOH2023-07-25
00810114911037SurgiTelSurgitelHOH2023-07-25
00810114911044SurgiTelSurgitelHOH2023-07-25
00810114911051SurgiTelSurgitelHOH2023-07-25
00810114911068SurgiTelSurgitelHOH2023-07-25
00810114911075SurgiTelSurgitelHOH2023-07-25
00810114911082SurgiTelSurgitelHOH2023-07-25
00810114911099SurgiTelSurgitelHOH2023-07-25
00810114911105SurgiTelSurgitelHOH2023-07-25
00810114911112SurgiTelSurgitelHOH2023-07-25
00810114911129SurgiTelSurgitelHOH2023-07-25
00810114911136SurgiTelSurgitelHOH2023-07-25
00810114910320SurgiTelSurgitelHOH2023-04-26
00810114910337SurgiTelSurgitelHOH2023-04-26
00810114910344SurgiTelSurgitelHOH2023-04-26
00810114910351SurgiTelSurgitelHOH2023-04-26
00810114910368SurgiTelSurgitelHOH2023-04-26
00810114910375SurgiTelSurgitelHOH2023-04-26
00810114910382SurgiTelSurgitelHOH2023-04-26