DEVICE: NopoGuard (00860011428404)

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Device Record History
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Device Identifier (DI) Information
NopoGuard
8000-01
In Commercial Distribution
NPG-SNG-PCK
Dental Products Lab, LLC
00860011428404
GS1

1
101657689 *Terms of Use
Dental needle safety device.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
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?
37461 Needle recapping device, reusable
A device intended to hold a needle cap and allow a user to conveniently recap a needle, providing some user protection against needle sticks. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DZM Needle, Dental
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status
3308ea27-812b-409a-9e06-582aac50a3a1
January 15, 2024
1
January 05, 2024
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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
No Package DIs found
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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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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