DEVICE: Comfort EZ Pro (00850002860726)

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Device Record History
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Device Identifier (DI) Information
Comfort EZ Pro
SPN-31G4
In Commercial Distribution
50002-0860-72
S.D.I. USA, INC.
00850002860726
GS1

100
116722847 *Terms of Use
Safety Insulin Pen Needles - 31G 4mm 100 count
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
No
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?
59230 Hypodermic needle, single-use
A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
Active false
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FDA Product Code

[?]
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
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
Needle Gauge: 31 Gauge
Length: 4 Millimeter
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Device Record Status
321123bb-8115-462d-abc3-ba74a1b98979
August 09, 2023
1
August 01, 2023
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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
10850002860723 12 00850002860726 In Commercial Distribution Case
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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

[?]
Unit of Use DI Number: 20850002860720 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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