AccessGUDID - DEVICE: PRO-Kinetic Energy (07640130435261)

GUDID

Device Identifier (DI) Information

Brand Name: PRO-Kinetic Energy
Version or Model: 3.5/30/140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 383905
Company Name: Biotronik AG

Primary DI Number: 07640130435261
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480862817 *Terms of Use

Device Description: No description.

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?
53616	Bare-metal coronary artery stent	A non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic heart disease. It is typically made of high-grade stainless steel or cobalt-chrome (Co-Cr), may be linear or have a bifurcation design (e.g., shaped as a Y in a tube form), and may be balloon-expanded or self-expandable. Dedicated disposable implantation devices (e.g., balloon catheter, delivery instrument) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAF	STENT, CORONARY

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: Keep away from sunlight Keep dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Usable Length: 140 cm
Device Size Text, specify: Length: 30 mm
Device Size Text, specify: Diameter: 3.5 mm

Device Record Status

Public Device Record Key: f7c720de-f297-4aa0-a6a5-f5b3dbe2689a
Public Version Date: October 07, 2019
Public Version Number: 3
DI Record Publish Date: March 02, 2017

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(888)345-0374
Email: jon.brumbaugh@biotronik.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES