AccessGUDID - DEVICE: Gimmi (04049047042884)

GUDID

Device Identifier (DI) Information

Brand Name: Gimmi
Version or Model: E.8290.11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E.8290.11
Company Name: Gimmi GmbH

Primary DI Number: 04049047042884
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316152610 *Terms of Use

Device Description: LAPAROSCOPE 10 MM 0° AUTOCLAVABLE ALPHASCOPE II WORKING LENGTH 330 MM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Flexible fibreoptic laparoscope	An 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.

GMDN Preferred Term Name

GMDN Definition

Flexible fibreoptic laparoscope

An 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.

FDA Product Code

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Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b524f639-ad33-4a1f-adb5-cb2c5f965172
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 05, 2017