AccessGUDID - DEVICE: Follicle Aspiration Set, Single Lumen (07350025914855)

GUDID

Device Identifier (DI) Information

Brand Name: Follicle Aspiration Set, Single Lumen
Version or Model: 14183
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vitrolife Sweden AB

Primary DI Number: 07350025914855
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631805488 *Terms of Use

Device Description: No description.

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):	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
IVF oocyte aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
MQE	Needle, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991273	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: d5f405e7-1bbe-4c28-9e5d-bc2a1f2feded
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016