FDA.reportPublic FDA data

Gimmi

Primary DI
04049047788522
Brand
Gimmi
Company
Gimmi GmbH
Model
LIG.4210.00
Catalog number
LIG.4210.00
Device description
AlphaSMART Light+ LED Light Source, NIR
Published
2025-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FCWLight Source, Fiberoptic, Routine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221591000Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light SourceSchoelly Fiberoptic GmbH2023-02-23GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047788522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047788522040490477885224049047788522

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049047110682GimmiZ.0005.23Z.0005.232017-05-05
04049047111146GimmiZ.0530.60Z.0530.602017-05-05
04049047111474GimmiZ.0560.01Z.0560.012017-05-05
04049047111528GimmiZ.0560.60Z.0560.602017-05-05
04049047111535GimmiZ.0561.01Z.0561.012017-05-05
04049047111559GimmiZ.0561.60Z.0561.602017-05-05
04049047111580GimmiZ.1025.24Z.1025.242017-05-05
04049047111597GimmiZ.1025.60Z.1025.602017-05-05
04049047111801GimmiZ.1139.02Z.1139.022017-05-05
04049047111818GimmiZ.1139.60Z.1139.602017-05-05
04049047111832GimmiZ.1140.02Z.1140.022017-05-05
04049047111849GimmiZ.1140.60Z.1140.602017-05-05
04049047111863GimmiZ.1235.02Z.1235.022017-05-05
04049047111870GimmiZ.1235.60Z.1235.602017-05-05
04049047113973GimmiZ.3035.60Z.3035.602017-05-05
04049047114055GimmiZ.3235.01Z.3235.012017-05-05
04049047114086GimmiZ.3235.31Z.3235.312017-05-05
04049047114109GimmiZ.3235.60Z.3235.602017-05-05
04049047114604GimmiZ.4536.02Z.4536.022017-05-05
04049047114611GimmiZ.4536.60Z.4536.602017-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826927669PENTAX MedicalPENTAX MEDICAL CORPORATIONFCW2026-08-25
04049047788607GimmiGimmi GmbHFCW2026-03-04
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFCW2025-06-11
00855373008029StrykerSUNOPTIC TECHNOLOGIES LLCFCW2025-05-15
04048551366813n.a.Karl Storz GmbH & Co. KGFCW2024-11-28
00840183528577BR Surgical, LLCBR Surgical, LLCFCW2024-10-24
04049197465007RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
04049197465069RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
00840183507763BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
00840183527341BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
04250480109045N/ASCHÖLLY FIBEROPTIC GmbHFCW2023-10-24
04961333071333PENTAXHOYA CORPORATIONFCW2023-07-31
04961333238088PENTAXHOYA CORPORATIONFCW2023-07-31
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCFCW2023-03-01
00840319710616Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710623Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710630Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710647Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710654Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710661Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710678Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710685Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710692Hayden MedicalHayden Medical, Inc.FCW2022-07-28
G043MLGA4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGA4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7ST0BEARBear-Ent, LLCFCW2022-05-19
07613327051568NASTRYKER CORPORATIONFCW2021-07-07