AccessGUDID - DEVICE: Sydney IVF (00827002463103)

GUDID

Device Identifier (DI) Information

Brand Name: Sydney IVF
Version or Model: G46310
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: K-SISP-100-AA
Company Name: WILLIAM A. COOK AUSTRALIA PTY. LTD.

Primary DI Number: 00827002463103
Issuing Agency: GS1
Commercial Distribution End Date: October 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 758568000 *Terms of Use

Device Description: SYDNEY IVF, SPERMIENT

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?
42850	IVF medium kit	A collection of solutions used to provide a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solutions typically contain various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). Some included solutions may indirectly support the IVF process. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQL	MEDIA, REPRODUCTIVE

FDA Premarket Submission

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

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
Special Storage Condition, Specify: Store in dark, dry, cool place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3154f3ed-0552-4ad8-991e-1c6f1f519bf8
Public Version Date: November 02, 2023
Public Version Number: 4
DI Record Publish Date: December 15, 2016