AccessGUDID - DEVICE: Blue Beacon(TM) GI Marker (06932503562027)

GUDID

Device Identifier (DI) Information

Brand Name: Blue Beacon(TM) GI Marker
Version or Model: P-DYZ-04-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503562027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Product is dark blue solution, the concentration is 0.4%, the content is 5ml. Initial packaging is the syringe.

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":	Yes
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?
17828	Tissue marking ink	A sterile liquid substance intended to be injected into tissue to identify lesions; it is also used externally on the skin to mark incision sites. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBG	Marker, Colon

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: 52bc17c8-70ec-494c-98cc-0c11d5d35934
Public Version Date: October 14, 2024
Public Version Number: 3
DI Record Publish Date: June 28, 2023