FDA.reportPublic FDA data

Gimmi

Primary DI
04049047670780
Brand
Gimmi
Company
Gimmi GmbH
Model
S.5105.50
Catalog number
S.5105.50
Device description
ALPHALEDLED LIGHT SOURCE
Published
2023-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NTNLed Light Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047670780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047670780040490476707804049047670780

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, line-poweredA mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags#

DUNS number
316152610
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049047155324GimmiAD.1753.202026-06-08
04049047003137GimmiAA.1502.192026-05-18
04049047787815GimmiLIG.4148.30LIG.4148.302025-03-20
04049047788119GimmiLIG.4148.98LIG.4148.982025-03-20
04049047657545NAE.8230.48 LED2023-05-03
04049047657569GimmiE.8300.48 LEDE.8300.48 LED2023-02-14
04049047042563GimmiE.8230.45XE.8230.45X2017-05-05
04049047043164GimmiE.8300.35E.8300.352017-05-05
04049047043171GimmiE.8300.48E.8300.482017-05-05
04049047043430GimmiE.8997.00E.8997.002017-05-05
04049047043447GimmiE.8998.01E.8998.012017-05-05
04049047126379GimmiE.8230.41E.8230.412017-05-05
04049047127086GimmiE.8000.00E.8000.002017-05-05
04049047127246GimmiE.8230.45X SETE.8230.45X SET2017-05-05
04049047203322GimmiE.8300.45XE.8300.45X2017-05-05
04049047631675GimmiE.8998.02E.8998.022017-05-05
04049047643289GimmiE.8300.48X SETE.8300.48X SET2017-05-05
04049047064725GimmiM.1701.08M.1701.082025-05-20
04049047064848GimmiM.1721.12M.1721.122017-05-05
04049047788553GimmiCAM.1113.002026-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817325025003iVisionMEDIMAX TECH INC.NTN2026-04-30
00851289007354FireflyFirefly GlobalNTN2025-07-18
00857556008642BR Surgical, LLCBR Surgical, LLCNTN2025-07-16
04547410513790FUJIFILMFUJIFILM CORPORATIONNTN2025-05-31
04580137732617MACHIDAMACHIDA ENDOSCOPE CO.,LTD.NTN2025-03-27
04953170458170OTV-S500 UPGRADE PACK STROBEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458231AIR MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458248MICROPHONE EXTENSION CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458255HDMI CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458354THROAT MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2025-02-28
04250480100271NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100288NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100295NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100325NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100349NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100356NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100363NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480101735NASCHÖLLY FIBEROPTIC GmbHNTN2024-12-03
04048551317488n.aKarl Storz GmbH & Co. KGNTN2024-11-29
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2024-11-14
00840183528522BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183528539BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183500474BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00857556008567BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCNTN2024-07-22
00840183500023BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
00840183500047BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2024-06-11