AccessGUDID - DEVICE: PALMAZ MULLINS XD Pulmonary Stent (20705032101216)

GUDID

Device Identifier (DI) Information

Brand Name: PALMAZ MULLINS XD Pulmonary Stent
Version or Model: PM3910PXD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PM3910PXD
Company Name: Cordis US Corp.

Primary DI Number: 20705032101216
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118274128 *Terms of Use

Device Description: PALMAZ MULLINS 8F UNEXP L29MM D10-12MM

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
63844	Bare-metal tracheal/bronchial/vascular stent	A non-bioabsorbable, tubular device intended to be implanted to indefinitely maintain patency/improve luminal diameter of a blood vessel (peripheral artery and/or vein) and, alternatively, the tracheobronchial tree; it may in addition be intended to be used in the biliary tract. It is not intended for implantation in a coronary or cerebral artery and not intended for shunting. It is a tubular bare-metal mesh implanted with a balloon catheter or delivery device (balloon and/or self-expanding). It is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QWC	Pulmonary Stent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220004	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
No Device Sizes

Device Record Status

Public Device Record Key: 1d8cd06a-c9a1-4056-9057-46739f1076f4
Public Version Date: June 09, 2025
Public Version Number: 1
DI Record Publish Date: May 31, 2025