AccessGUDID - DEVICE: VisionAir 3D Stent (00811813020525)

GUDID

Device Identifier (DI) Information

Brand Name: VisionAir 3D Stent
Version or Model: 0010-0126
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

Primary DI Number: 00811813020525
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 078667390 *Terms of Use

Device Description: Patient-Specific Silicone Airway Stent

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":	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
NWA	Prosthesis, Tracheal, Preformed/Molded

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3124b1a1-007f-4260-b90d-fe908b0f9dc6
Public Version Date: May 02, 2024
Public Version Number: 2
DI Record Publish Date: March 11, 2024