AccessGUDID - DEVICE: BlueBoost(TM) Submucosal Injectable Solution (06932503562515)

GUDID

Device Identifier (DI) Information

Brand Name: BlueBoost(TM) Submucosal Injectable Solution
Version or Model: SML05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503562515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Product is sky-blue viscous liquid, 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?
60785	Injectable charcoal tattoo marker	An implantable suspension of charcoal intended to be injected subcutaneously (e.g., under ultrasound imaging) to mark the skin over the site of a lump/lesion, or into deeper tissues to provide a visual mark for subsequent surgical excision. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PLL	Submucosal Injection Agent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200071	000

Device Exempt from Premarket Submission: No 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: d46b125c-e4b8-4639-a03a-f821ae1cdaa8
Public Version Date: October 14, 2024
Public Version Number: 5
DI Record Publish Date: June 28, 2023