AccessGUDID - DEVICE: EZ-Strip (05060170181423)

GUDID

Device Identifier (DI) Information

Brand Name: EZ-Strip
Version or Model: 170 micron tip id
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7-72-1170/20
Company Name: RESEARCH INSTRUMENTS LIMITED

Primary DI Number: 05060170181423
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 536139413 *Terms of Use

Device Description: Assisted Reproduction Microtools (Pipettes)

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
MQH	MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991261	000

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
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep away from direct sunlight (UV)

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 170 Micrometer

Device Record Status

Public Device Record Key: c127382c-7142-48b2-b180-3440091f39b1
Public Version Date: February 28, 2024
Public Version Number: 4
DI Record Publish Date: September 17, 2016