FDA.reportPublic FDA data

Gimmi

Primary DI
04049047715412
Brand
Gimmi
Company
Gimmi GmbH
Model
QO.2291.00
Catalog number
QO.2291.00
Device description
HOUSE-BARBARA NEEDLESTRAIGHT, 1.0 MMLENGTH 170 MM
Published
2025-05-20
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
JYTPick, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYTPick, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049047715412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049047715412040490477154124049047715412

GMDN Terms#

Term, Definition table
TermDefinition
Pericardiocentesis needle, reusableA sharp bevel-edged, hollow tubular metal instrument specifically designed for the puncture of the pericardial cavity for the aspiration (removal) of fluids (pericardiocentesis). The device is typically long and rigid enough to penetrate the pericardium (e.g., 10 to 18 centimetres in length). 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
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
04049047788577GimmiCAM.1113.902026-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421571MillenniumAvalign Technologies, Inc.JYT2026-05-05
09348811111975INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-04-24
09348811022677INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-18
09348811111906INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811112002INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811150288INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
09348811150356INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
00757770682539Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
00757770714049Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
09348811111968INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811112019INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811155344INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811109828INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109835INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109842INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109859INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111913INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111920INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111937INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811150295INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
00190776413200MillenniumAvalign Technologies, Inc.JYT2025-10-09
G04365983B0BEARBear-Ent, LLCJYT2024-02-03
14026704804662PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704804679PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704804686PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704804822PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704805058PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704805065PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704805072PILLINGTELEFLEX INCORPORATEDJYT2022-12-08
14026704805089PILLINGTELEFLEX INCORPORATEDJYT2022-12-08