AccessGUDID - DEVICE: Gongdong (06947462492247)

GUDID

Device Identifier (DI) Information

Brand Name: Gongdong
Version or Model: E1030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 06947462492247
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 9600
Labeler D-U-N-S® Number*: 529309049 *Terms of Use

Device Description: Pipette Tip

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):	No
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?
16822	Pipette tip	A device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette or a dispenser and where the required volume of liquid is drawn for delivery to the target receptacle. It may show a gradient scale or not and is usually made of plastic but may also be made of glass. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eff8fb04-33b0-4395-b63e-40a2b67fd84d
Public Version Date: August 12, 2022
Public Version Number: 1
DI Record Publish Date: August 04, 2022