FDA.reportPublic FDA data

Portegra2

Primary DI
04251339900189
Brand
Portegra2
Company
MAVIG GmbH
Model
LE70U627
Catalog number
E-LE70U627
Device description
Portegra2 Extension/Spring Arm (750/910 mm, electrical)
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSYLight, Surgical, Ceiling Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251339900189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251339900189042513399001894251339900189

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light mountA permanently-fixed structure designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. The mount is intended to be permanently-fixed to the ceiling and/or wall. This device will be designed to enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device to be mounted (medical light/monitor) is not included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317502326
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251339907669OTOT0294-EMC2026-04-14
04251339901520WDWD260/100/120E2026-02-12
04251339906082WDWD204-05172026-02-12
04251339906815UTUT70-10WS-PH2026-02-12
04251339906822OTOT5500292026-02-12
04251339907263OTOT5100252026-02-12
04251339907270OTOT5000892026-02-12
04251339907287OTOT5400342026-02-12
04251339907294OTOT580012026-02-12
04251339907393UTE-UT60U0642026-02-12
04251339907409OTE-OT54B01V50S2026-02-12
04251339906242RPRP6435M22SB12-PH2024-06-03
04251339906259RPRP6435L22SB12-PH2024-06-03
04251339906266RPRP6435X22SB12-PH2024-06-03
04251339906273RPRP6435S22SB12-PH2024-06-03
04251339906280OTOT54001I-MQ2024-06-03
04251339906297OTOT50001I-MQ2024-06-03
04251339906006OTPTZTS2002OT812024-04-19
04251339906013OTPTZTS2005OT812024-04-19
04251339900370WDWD26105 2023-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00684706009842iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009859iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009835iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-06
10192253051988DevonCardinal Health 200, LLCFSY2026-03-11
00684706009804iCE Surgical LightAmico Clinical Solutions CorpFSY2025-10-09
50192253021521DevonCardinal Health 200, LLCFSY2025-06-16
50192253053096DevonCardinal Health 200, LLCFSY2025-06-09
10192253052008DevonCardinal Health 200, LLCFSY2025-04-14
20192253051961DevonCardinal Health 200, LLCFSY2025-04-14
20192253051978DevonCardinal Health 200, LLCFSY2025-04-14
20192253051992DevonCardinal Health 200, LLCFSY2025-04-14
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
00684706007442iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007459iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007466iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007473iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007480iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007497iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007428iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007435iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007404iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00684706007411iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00724995199364HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199388HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199395HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199401HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199425HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199432HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199456HarmonyAIRSTERIS CORPORATIONFSY2021-04-09