AccessGUDID - DEVICE: Orsiro (07640130439030)

GUDID

Device Identifier (DI) Information

Brand Name: Orsiro
Version or Model: 2.5/18/140
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 401748
Company Name: Biotronik AG

Primary DI Number: 07640130439030
Issuing Agency: GS1
Commercial Distribution End Date: September 09, 2024
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:	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?
58771	Drug-eluting coronary artery stent, bioabsorbable-polymer-coated	A non-bioabsorbable metal tubular mesh structure covered with a bioabsorbable polymer that contains a drug, designed to be implanted via a delivery catheter into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug is slowly released as the polymer degrades and is intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Some types may be dedicated to implantation across a coronary artery bifurcation. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIQ	Coronary drug-eluting stent

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 Store in a dry location
Storage Environment Temperature: less than 77 Degrees Fahrenheit
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length: 18 mm
Device Size Text, specify: Usable Length: 140 cm
Device Size Text, specify: Diameter: 2.5 mm

Device Record Status

Public Device Record Key: 4313823f-5bb5-476a-bd91-146fd28a42df
Public Version Date: September 10, 2024
Public Version Number: 3
DI Record Publish Date: February 26, 2019