AccessGUDID - DEVICE: Orsiro Mission (07640130456211)

GUDID

Device Identifier (DI) Information

Brand Name: Orsiro Mission
Version or Model: 3.5/30/140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 453965
Company Name: Biotronik AG

Primary DI Number: 07640130456211
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:	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
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep dry Keep away from sunlight
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 374e1527-4ba7-4652-bd95-06351d3b35d4
Public Version Date: December 12, 2024
Public Version Number: 3
DI Record Publish Date: July 08, 2021

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