DEVICE: Azur Pure Helical (00810170018275)

Device Identifier (DI) Information

Azur Pure Helical
45-081014
In Commercial Distribution
45-081014
MICROVENTION INC.
00810170018275
GS1

1
003263105 *Terms of Use
Azur
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Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
KRD Device, Vascular, for Promoting Embolization
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 10 mm x 14 cm
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Device Record Status

bfc08bab-d107-4c8d-8ed4-f63447274e61
March 28, 2022
6
December 29, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10810170018272 3 00810170018275 In Commercial Distribution Carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(714)247-8000
customerservice@microvention.com
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