AccessGUDID - DEVICE: ARTHROFLATOR (04048551405055)

GUDID

Device Identifier (DI) Information

Brand Name: ARTHROFLATOR
Version or Model: 28803C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Karl Storz GmbH & Co. KG

Primary DI Number: 04048551405055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315731430 *Terms of Use

Device Description: Arthroflator w. German connection

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
Surgical irrigation/aspiration system pump	A mains electricity (AC-powered) device used to generate positive and/or negative pressures as part of an irrigation/aspiration system used during a general surgical procedure to intermittently or continuously irrigate and/or aspirate body cavities and wounds. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

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

[?]

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: 311bbe52-49e6-40ed-a01c-9d3865c6c568
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016