AccessGUDID - DEVICE: Gynosampler (05425017500377)

GUDID

Device Identifier (DI) Information

Brand Name: Gynosampler
Version or Model: #9164
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gynetics Medical Products NV

Primary DI Number: 05425017500377
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 283088573 *Terms of Use

Device Description: The Gynosampler is an endometrial suction curette for a histologic lining biopsy.

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
Endometrial biopsy kit	A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
HFF	Aspirator, Endometrial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K903002	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Outer Diameter: 2.93 Millimeter
Length: 262 Millimeter

Device Record Status

Public Device Record Key: c96be6b0-7813-4653-b746-1c139e6f4b25
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: October 04, 2016