AccessGUDID - DEVICE: Echosampler (05425017500032)

GUDID

Device Identifier (DI) Information

Brand Name: Echosampler
Version or Model: #5164 Echosampler
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gynetics Medical Products NV

Primary DI Number: 05425017500032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 283088573 *Terms of Use

Device Description: Endometrial curette

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11531	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.	Active	false

FDA Product Code

[?]

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

[?]

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

Device Record Status

Public Device Record Key: 22a1ed66-74c7-4db1-9b92-7261e0bcc144
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: January 17, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
25425017500036	125	05425017500032		In Commercial Distribution
15425017500039	25	05425017500032		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +3211645872
Email: info@gynetics.be

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