AccessGUDID - DEVICE: Single Use Surgical Professional (05055299103562)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use Surgical Professional
Version or Model: S301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S301
Company Name: PELICAN FEMININE HEALTHCARE LIMITED

Primary DI Number: 05055299103562
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 239505063 *Terms of Use

Device Description: Myringotomy Kit 1

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:	Yes
Prescription Use (Rx):	No
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
General/plastic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KDD	Kit, Surgical Instrument, Disposable

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: c1e1cdf6-6542-4ee3-b1c3-5571f325e44b
Public Version Date: May 08, 2018
Public Version Number: 3
DI Record Publish Date: August 09, 2016