DEVICE: PAROJECT (00303620000024)

Device Identifier (DI) Information

PAROJECT
01N2040
In Commercial Distribution
01N2040
SEPTODONT, INC
00303620000024
GS1

1
012925513 *Terms of Use
Dental cartridge syringe
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental anaesthesia syringe A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
EGM Injector, Jet, Mechanical-Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K904279 000
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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
Total Volume: 1.8 Milliliter
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Device Record Status

ad353efc-a3da-42de-a7ec-32c4f9e0dd8b
July 06, 2018
3
September 15, 2016
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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)

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

[?]
Yes
No
No
No
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Customer Contact

[?]
(303) 665-7535
usregulatoryaffairs@septodont.com
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