AccessGUDID - DEVICE: Kitazato ReproPlate-K6 (04582231462421)

GUDID

Device Identifier (DI) Information

Brand Name: Kitazato ReproPlate-K6
Version or Model: ReproPlate-K6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83020
Company Name: KITAZATO CORPORATION

Primary DI Number: 04582231462421
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711091157 *Terms of Use

Device Description: 10 Packs

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):	No
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
PUD	Labware, assisted reproduction, exempt

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 24ed4ca4-832f-4bd9-b986-7ea27d12f032
Public Version Date: September 21, 2023
Public Version Number: 2
DI Record Publish Date: September 01, 2023