AccessGUDID - DEVICE: Dynamic™ Y Stent (08714729764823)

GUDID

Device Identifier (DI) Information

Brand Name: Dynamic™ Y Stent
Version or Model: 7068
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7068
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729764823
Issuing Agency: GS1
Commercial Distribution End Date: March 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Dynamic™ (Y) Stent

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?
46977	Polymeric tracheal/bronchial stent, non-bioabsorbable	A non-bioabsorbable tubular device intended to be implanted into the trachea and/or a bronchus/bronchiole to maintain luminal patency, typically used in cases of obstructions/stenoses, fistulae, tumours, scarring, surgical resection and anastomosis, or pulmonary transplantation. It is made entirely of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., semi-soft continuous tube, covered or non-covered mesh structure, straight or branched configuration) intended to conform to the endotracheal/endobronchial surface. It may be expandable in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NYT	Prosthesis, tracheal, expandable, polymeric

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: 15 mm Internal Diameter

Device Record Status

Public Device Record Key: 2a46002d-8f8d-4ed5-b756-0a40257cfcc0
Public Version Date: May 15, 2024
Public Version Number: 2
DI Record Publish Date: December 14, 2018