AccessGUDID - DEVICE: Tracheal Stent system (Y-shaped) (06932503581783)

GUDID

Device Identifier (DI) Information

Brand Name: Tracheal Stent system (Y-shaped)
Version or Model: NST02-962-20.050-106
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503581783
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: Y-shaped, main body20×50,one branch14×30, the other branch14×20, Partially Covered, Delivery System 8×650

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
43630	Polymer-metal tracheal/bronchial stent	A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body with metallic support structures), and may have a straight or branched configuration. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JCT	Prosthesis, Tracheal, Expandable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212403	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
Stent Diameter: 20 Millimeter
Stent Length: 50 Millimeter

Device Record Status

Public Device Record Key: 3fafa4af-ad3e-43a7-b160-83e059baec57
Public Version Date: October 14, 2024
Public Version Number: 3
DI Record Publish Date: February 03, 2023