AccessGUDID - DEVICE: LifeGlobal® Micropipet (00815965021867)

GUDID

Device Identifier (DI) Information

Brand Name: LifeGlobal® Micropipet
Version or Model: MPBL-35B*01*
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MPBL-35B*01*
Company Name: LIFEGLOBAL GROUP, LLC

Primary DI Number: 00815965021867
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 141732011 *Terms of Use

Device Description: LG µPipets®: Blastomere Biopsy, 35° - GREEN (1pc)

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?
46553	Assisted reproduction microtool	A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQJ	MICROMANIPULATORS AND MICROINJECTORS, 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: Do not use if package is damaged
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Inner Diameter 30-35µm
Device Size Text, specify: angle of tip
Angle: 35 degree
Device Size Text, specify: beveled tip

Device Record Status

Public Device Record Key: 48ef8b53-79e5-4345-9bdc-1dc6e583bc4a
Public Version Date: July 03, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016