Cotton Plugged IVF Pasteur Pipets

Basic Information

• Brand Name: Cotton Plugged IVF Pasteur Pipets
• Primary DI: 50888937014124
• Version / Model: PP-9-90PL
• Company Name: Coopersurgical, Inc.
• Labeler DUNS: 801895244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: f12fc576-57ed-4340-a0de-3cffb17f9089

Device Description

Origio, Inc. 9" (22.9 cm) Cotton Plugged IVF Pasteur Pipets

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	884.6160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43375	User-induced pipette	A device designed for the manual withdrawal, transfer, and injection of small volumes of fluid materials. It is made of glass or plastic and is designed as a long thin tube, typically with graduations along its length. The user will typically attach a mouthpiece and create a partial vacuum within the pipette by gently sucking the air from inside the tube inducing the liquid to enter the pipette, or achieve the same action with a squeezable bulb. Closing the mouthpiece or the user end of the pipette will hold the liquid therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888937014123	GS1		30	In Commercial Distribution
Primary	50888937014124	GS1

Premarket Submissions

Submission Number	Supplement Number
K000915	000