FDA.reportPublic FDA data

SurgiTel

Primary DI
00810114910344
Brand
SurgiTel
Company
Surgitel
Model
EVC250N FLM
Device description
Optical assembly for magnified view and more ergonomic posture for surgical and dental procedures.
Published
2023-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOHSpectacle, Operating (Loupe), Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOHSpectacle, Operating (Loupe), OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810114910344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810114910344008101149103448101149103440810114910344

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
078566956
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810114911006SurgiTelTTL Loupe2023-07-25
00810114911013SurgiTelFLM Loupe2023-07-25
00810114911020SurgiTelHeadband Loupe2023-07-25
00810114911037SurgiTelWired Light2023-07-25
00810114911044SurgiTelWireless Light2023-07-25
00810114911051SurgiTelSurgiCam2023-07-25
00810114911068SurgiTelTTL Loupe, Wired Light2023-07-25
00810114911075SurgiTelTTL Loupe, Wireless Light2023-07-25
00810114911082SurgiTelFLM Loupe, Wired Light2023-07-25
00810114911099SurgiTelFLM Loupe, Wireless Light2023-07-25
00810114911105SurgiTelHeadband Loupe, Wired Light2023-07-25
00810114911112SurgiTelHeadband Loupe, Wireless Light2023-07-25
00810114911129SurgiTelSurgiCam, Wired Light2023-07-25
00810114911136SurgiTelSurgiCam, Wireless Light2023-07-25
00810114910320SurgiTelEVC250F FLM2023-04-26
00810114910337SurgiTelEVC250M FLM2023-04-26
00810114910351SurgiTelEVC250XF FLM2023-04-26
00810114910368SurgiTelEVC300F FLM2023-04-26
00810114910375SurgiTelEVC300M FLM2023-04-26
00810114910382SurgiTelEVC300N FLM2023-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049584035714BIOM 6 HD Optic Set for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
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
04049539106889EyeMag Smart TTLCarl Zeiss Meditec AGHOH2025-01-22
04049539106896EyeMag ClassicCarl Zeiss Meditec AGHOH2025-01-22
04049584029591BIOM ready+ 175, for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049584029607BIOM ready+ 200, for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
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