AccessGUDID - DEVICE: Zilver PTX (10827002384146)

GUDID

Device Identifier (DI) Information

Brand Name: Zilver PTX
Version or Model: G38414
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZISV6-35-125-5-100-PTX
Company Name: COOK IRELAND LTD

Primary DI Number: 10827002384146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 988559035 *Terms of Use

Device Description: Zilver PTX, Drug-Eluting Peripheral Stent

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:	Yes
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?
46919	Drug-eluting peripheral artery stent, bare-metal	A non-bioabsorbable metal tubular mesh structure with a drug coating intended to be implanted into a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain luminal patency typically in patients with symptomatic peripheral artery disease; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. The drug coating is slowly released and intended to inhibit restenosis. Disposable devices associated with implantation (e.g., delivery catheter) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIU	Stent, superficial femoral artery, drug-eluting

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dark, dry, cool place. Avoid extended exposure to light.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3db8fbaf-ff65-4a17-827f-82a467c3116c
Public Version Date: December 11, 2024
Public Version Number: 5
DI Record Publish Date: December 13, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(812)330-5494
Email: sharedservices@cookmedical.com

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