AccessGUDID - DEVICE: ENDOFLATOR (04048551068793)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOFLATOR
Version or Model: 26430520-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551068793
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Electronic CO2 ENDOFLATOR® SCB

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
Laparoscopic insufflator	A mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system.

GMDN Preferred Term Name

GMDN Definition

Laparoscopic insufflator

A mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system.

FDA Product Code

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Product Code	Product Code Name
HIF	INSUFFLATOR, LAPAROSCOPIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080852	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 36715b2f-c959-41c9-8f0c-edf3b6f7ce6f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016