FDA.report

Gimmi

Primary DI
04049047042907
Brand
Gimmi
Company
Gimmi GmbH
Model
E.8290.53
Catalog number
E.8290.53
Device description
LAPAROSCOPE AUTOCLAVABLE 5 MM 0° HM WORKING LENGTH 300 MM
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049047042907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049047042907040490470429074049047042907

GMDN Terms

TermDefinition
Flexible fibreoptic laparoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle. The abdominal wall is distended, typically using a gas distention device, providing space to allow the surgeon to directly view and/or operate on the exposed organs. It is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and to perform female sterilization. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags

DUNS number
316152610
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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04049047075318GimmiQO.1003.05QO.1003.052025-05-21
04049047075325GimmiQO.1003.06QO.1003.062025-05-21
04049047075332GimmiQO.1003.08QO.1003.082025-05-21
04049047075417GimmiQO.1005.04QO.1005.042025-05-21
04049047075424GimmiQO.1005.05QO.1005.052025-05-21
04049047075431GimmiQO.1005.06QO.1005.062025-05-21
04049047076452GimmiQO.1170.03QO.1170.032025-05-21
04049047076469GimmiQO.1170.04QO.1170.042025-05-21
04049047076612GimmiQO.1173.03QO.1173.032025-05-21
04049047077077GimmiQO.1430.08QO.1430.082025-05-21
04049047077084GimmiQO.1430.14QO.1430.142025-05-21
04049047078005GimmiQO.2050.04QO.2050.042025-05-21
04049047078043GimmiQO.2052.02QO.2052.022025-05-21

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