AccessGUDID - DEVICE: Azur Pure Helical (00810170018701)

GUDID

Device Identifier (DI) Information

Brand Name: Azur Pure Helical
Version or Model: 45-050706
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 45-050706
Company Name: MICROVENTION INC.

Primary DI Number: 00810170018701
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 003263105 *Terms of Use

Device Description: Azur

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":	Yes
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?
35499	Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to Adenovirus in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRD	Device, Vascular, for Promoting Embolization

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 7 mm x 6 cm

Device Record Status

Public Device Record Key: 46385efb-9e5e-4bb0-8f76-0a08daf3b0c9
Public Version Date: March 28, 2022
Public Version Number: 6
DI Record Publish Date: December 29, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10810170018708	3	00810170018701		In Commercial Distribution	Carton

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: Yes
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(714)247-8000
Email: customerservice@microvention.com

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

FDA TOOLS & RESOURCES