AccessGUDID - DEVICE: Twinkle Pro with Soft Obturator (00819374021852)

GUDID

Device Identifier (DI) Information

Brand Name: Twinkle Pro with Soft Obturator
Version or Model: TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Soft Obturator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TPEB-ETC-SB
Company Name: ALLWIN MEDICAL DEVICES, INC.

Primary DI Number: 00819374021852
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796354509 *Terms of Use

Device Description: TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Soft Obturator

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?
45846	Assisted reproduction transfer catheter/set	A device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQF	Catheter, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200248	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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d9fed2cc-4356-45dc-a6c5-0b96d112e3ad
Public Version Date: September 28, 2020
Public Version Number: 1
DI Record Publish Date: September 18, 2020