FDA.reportPublic FDA data

Gimmi

Primary DI
04049047000884
Brand
Gimmi
Company
Gimmi GmbH
Model
AA.0912.06
Catalog number
AA.0912.06
Device description
SCHINK SKIN STRAIGHTENING PLATEONLYFOR AA.0912.00
Published
2025-04-16
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
EMFKnife, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047000884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047000884040490470008844049047000884

GMDN Terms#

Term, Definition table
TermDefinition
Dermatome handleA hand-held manual surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade (not included). 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
Premarket exempt
true
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
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
00810238290131PRINCETONPrinceton Medical Group, Inc.EMF2026-10-23
00724995268367Snowden-PencerSTERIS Deutschland GmbHEMF2026-09-25
00198506093104ELMED INCORPORATEDELMED INCORPORATEDEMF2026-07-28
00190776395476MillenniumAvalign Technologies, Inc.EMF2026-07-14
00810189450691Surgical DesignSurgical Design, Inc.EMF2026-06-06
00810189450707Surgical DesignSurgical Design, Inc.EMF2026-06-06
00848530100162Disposable Wire-Guided Scapel for Central Venous CannulationSunset Healthcare Solutions, Inc.EMF2025-12-09
00848530100179GuideBlade Sample KitSunset Healthcare Solutions, Inc.EMF2025-12-09
00198506085659ELMED INCORPORATEDELMED INCORPORATEDEMF2025-10-02
10888277370647MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-02-14
10888277377615MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-01-21
00860010523902VECTRRafael Medical Devices, LLCEMF2025-01-10
00842180160613ELMEDELMED INCORPORATEDEMF2023-01-30
00842180147737ELMEDELMED INCORPORATEDEMF2022-12-22
14026704810861PILLINGTELEFLEX INCORPORATEDEMF2022-12-08
00192896113701Cottle Mucosa KnifeSONTEC INSTRUMENTS, INC.EMF2022-09-15
00847399017239MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
00847399017246MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
10888277370623MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
10888277370630MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
00847399016003MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016010MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016034MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016935MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016942MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
20630140057523CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
20630140057530CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
00848782025527StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025541StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025572StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29