DEVICE: Pentips (00384703490017)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMI | Needle, Hypodermic, Single Lumen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152339 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Needle Gauge: 31 Gauge |
Length: 6 Millimeter |
Device Record Status
e7d257b6-3945-4aac-af40-11223e2ef5f7
January 13, 2022
4
September 19, 2016
January 13, 2022
4
September 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00384703490024 | 10 | 00384703490017 | In Commercial Distribution | Sleeve | |
00384703490031 | 50 | 00384703490024 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00384703490000
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
770-977-2226
info@owenmumfordinc.com
info@owenmumfordinc.com