AccessGUDID - DEVICE: 35X10 IVF PETRIDISH NONTREATED VENTS (05713311000045)

GUDID

Device Identifier (DI) Information

Brand Name: 35X10 IVF PETRIDISH NONTREATED VENTS
Version or Model: 150255
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 150255
Company Name: Nunc A/S

Primary DI Number: 05713311000045
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 500
Labeler D-U-N-S® Number*: 305971764 *Terms of Use

Device Description: No description.

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?
56648	Assisted reproduction procedure dish	A container intended exclusively for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 75b34bea-1bd1-4fca-889a-8d3e86fd1f0e
Public Version Date: February 20, 2023
Public Version Number: 8
DI Record Publish Date: September 01, 2016