DEVICE: AboutTime 32G x 4mm Pen Neddles (00628465045215)

Device Identifier (DI) Information

AboutTime 32G x 4mm Pen Neddles
1
In Commercial Distribution

Medical Plastic Devices M.P.D. Inc
00628465045215
GS1

100
244897773 *Terms of Use
AboutTime 32G x 4mm Pen Neddles, Universal fit
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
No
Yes
No
No
No

GMDN

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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.
Active false
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FDA Product Code

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Product Code Product Code Name
FMI Needle, Hypodermic, Single Lumen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9b5720b4-3842-4482-99f1-3f492c1da2e8
March 03, 2020
1
February 24, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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

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Unit of Use DI Number: 00628465145212 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
Yes CLOSE

Customer Contact

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No Customer Contact currently defined
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