FDA.reportPublic FDA data

Gimmi

Primary DI
04049047667827
Brand
Gimmi
Company
Gimmi GmbH
Model
R.0100.00 II
Catalog number
R.0100.00 II
Device description
SCREEN BASKET LID 1/1 STAINLESS STEEL PERFORATED 543 X 253 MM
Published
2025-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123234000ERMIS STERILIZATION CONTAINER SYSTEMErmis Medizintechnik2013-07-05KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047667827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047667827040490476678274049047667827

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
316152610
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049047121121GimmiQR.0750.00QR.0750.002025-05-21
04049047074694GimmiPU.1628.192026-08-14
04049047640868GimmiT.0120.62T.0120.622016-09-20
04049047640905GimmiT.0120.65T.0120.652017-05-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095044INSTRUSAFESummit Medical, Inc.KCT2026-10-13
04255858312607HIP TRIAL TRAYHermann Müller Medizintechnik GmbHKCT2026-10-13
04255858312614HIP/ KNEE TRIAL TRAY LIDHermann Müller Medizintechnik GmbHKCT2026-10-13
04255858312638KNEE TRIAL TRAYHermann Müller Medizintechnik GmbHKCT2026-10-13
G476STER16X525X15SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-13
G476STER20X10X3SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-13
00643169236967n/aMEDTRONIC SOFAMOR DANEK, INC.KCT2026-10-11
00643169236974n/aMEDTRONIC SOFAMOR DANEK, INC.KCT2026-10-11
00643169236981n/aMEDTRONIC SOFAMOR DANEK, INC.KCT2026-10-11
00385640094887INSTRUSAFESummit Medical, Inc.KCT2026-10-09
00385640094894INSTRUSAFESummit Medical, Inc.KCT2026-10-09
00190776436193MillenniumAvalign Technologies, Inc.KCT2026-10-08
00385640094870INSTRUSAFESummit Medical, Inc.KCT2026-10-08
00385640094832INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094849INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094856INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094863INSTRUSAFESummit Medical, Inc.KCT2026-10-07
00385640094795INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094801INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094818INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094825INSTRUSAFESummit Medical, Inc.KCT2026-10-06
00385640094726INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094733INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094740INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094757INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094764INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094771INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00385640094788INSTRUSAFESummit Medical, Inc.KCT2026-10-05
00724995238360V. MuellerSteris CorporationKCT2026-10-05
00385640094689INSTRUSAFESummit Medical, Inc.KCT2026-10-01