AccessGUDID - DEVICE: DEWIN (16972962310040)

GUDID

Device Identifier (DI) Information

Brand Name: DEWIN
Version or Model: D-ICSI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9201-30-10
Company Name: DonneVie Medical Technology(Shanghai)Co.Ltd

Primary DI Number: 16972962310040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554479334 *Terms of Use

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

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 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.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 39f9f6d6-87fe-4e92-a681-17bc3884459d
Public Version Date: July 23, 2024
Public Version Number: 1
DI Record Publish Date: July 15, 2024