DEVICE: MICRON, droplet pen needle (05907996096152)
Device Identifier (DI) Information
MICRON, droplet pen needle
34G x 3.5mm
In Commercial Distribution
7914
HTL STREFA S A
34G x 3.5mm
In Commercial Distribution
7914
HTL STREFA S A
Sterile, single use MICRON, droplet pen needles, intended to be used with a pen injector device for the subcutaneous injection of insulin.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
44127 | Autoinjector needle |
A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMI | Needle, Hypodermic, Single Lumen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 14 and 113 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 34G x 9/64" / 0.18mm x 3.5mm |
Device Record Status
43a744f3-cbae-4b6b-8bd6-629739631832
February 03, 2020
1
January 24, 2020
February 03, 2020
1
January 24, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
15907996096159 | 12 | 05907996096152 | In Commercial Distribution | Shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
85907996096158
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1-770-528-0410
info@mydroplet.com
info@mydroplet.com