DEWIN

Basic Information

• Brand Name: DEWIN
• Primary DI: 16972962310729
• Version / Model: D-ICSI
• Catalog Number: 9207-20-8
• Company Name: DonneVie Medical Technology(Shanghai)Co.Ltd
• Labeler DUNS: 554479334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-15
• Public Version: 1
• Public Version Date: 2024-07-23
• Public Version Status: New
• Public Device Record Key: c3a38c0e-8d66-456a-9489-b711593e0683

Device Description

Micromanipulation pipette is a disposable sterile product made of borosilicate glass for in vitro cell manipulation.The D-ICSI pipette is used to inject single sperm into oocytes.

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: Yes
• 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
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	884.6130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45410	User-induced micropipette	A long, thin tube made of glass or plastic typically used in the laboratory for the manual withdrawal, transfer, and injection of minute volumes of fluid materials (e.g., microlitres or smaller). The user will typically attach a mouthpiece and create a partial vacuum within the device by gently sucking the air from inside the tube, inducing the substance to enter the device, or achieve the same action with a sqeezable bulb/syringe. Closing the mouthpiece or the user end of the pipette will hold the substance therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb/syringe. Device use may include in vitro fertilization (IVF) procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	16972962310729	GS1
Package	36972962310723	GS1	BOX	10	In Commercial Distribution

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The micromanipulation pipette should be stored in a dry, ventilated environment away from light. It should be handled with care, protect from pressure, fall, rain and snow splash.