AccessGUDID - DEVICE: HOC COLLECTION VIAL 30ML (03700111400863)

GUDID

Device Identifier (DI) Information

Brand Name: HOC COLLECTION VIAL 30ML
Version or Model: HOC COLLECTION VIAL 30ML
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1302001
Company Name: LABORATOIRE CCD

Primary DI Number: 03700111400863
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381633924 *Terms of Use

Device Description: Device for oocyte collection

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?
57834	Assisted reproduction cryotube	A sterile container (a dedicated sealable tube) intended for transport, storage and preparation of biological samples of human origin used in assisted reproduction techniques (ART), e.g., embryos. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF) and ART clinics. Its main application being to hold biological materials when stored in a frozen state at temperatures below -130 Celsius (e.g., stored in the gas phase above the liquid nitrogen (LN2) at temperatures around -178 C to -150 C). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQE	NEEDLE, ASSISTED REPRODUCTION

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: -The product must not be used in the event of damaged, or open primary packaging before the medical procedure. -Store away from direct sunlight. -Store in a dry place.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 30 Milliliter

Device Record Status

Public Device Record Key: ebbf86b1-9336-4160-b786-593ba7681552
Public Version Date: December 13, 2023
Public Version Number: 1
DI Record Publish Date: December 05, 2023